Page last updated: 2024-10-29

avapro and Cirrhosis

avapro has been researched along with Cirrhosis in 21 studies

Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.
irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension.

Research Excerpts

ExcerptRelevanceReference
"The aim of this study was to investigate the effect of canagliflozin (CANA) on ventricular remodeling in patients with preserved ejection fraction (HFpEF) heart failure and to further investigate its possible molecular mechanisms."8.31Canagliflozin Ameliorates Ventricular Remodeling through Apelin/Angiotensin-Converting Enzyme 2 Signaling in Heart Failure with Preserved Ejection Fraction Rats. ( Guo, Y; He, L; Ma, S; Wang, X; Wang, Y; Wang, Z; Zhai, J; Zhang, G; Zhang, T; Zuo, Q, 2023)
"To compare the potential beneficial effects of the angiotensin converting enzyme inhibitor (ACEI) benazepril and the angiotensin II receptor 1 blocker (ARB) irbesartan on vaginal vascular remodeling and fibrosis in female spontaneously hypertensive rats (SHRs)."7.96Protective effects of irbesartan and benazepril against vaginal vascular remodeling and fibrosis in female spontaneously hypertensive rats. ( Li, N; Liang, W; Ma, R; Wang, Q; Yu, J; Yu, X; Zhao, X; Zhao, Y, 2020)
"Angiotensin II (Ang II) can induce cardiac fibrosis, but the underlying mechanisms are incompletely understood."7.72Cardiac fibrosis occurs early and involves endothelin and AT-1 receptors in hypertension due to endogenous angiotensin II. ( Belloni, AS; Kreutz, R; Nussdorfer, GG; Paul, M; Pessina, AC; Rossi, GP; Seccia, TM, 2003)
"The aim of this study was to investigate the effect of canagliflozin (CANA) on ventricular remodeling in patients with preserved ejection fraction (HFpEF) heart failure and to further investigate its possible molecular mechanisms."4.31Canagliflozin Ameliorates Ventricular Remodeling through Apelin/Angiotensin-Converting Enzyme 2 Signaling in Heart Failure with Preserved Ejection Fraction Rats. ( Guo, Y; He, L; Ma, S; Wang, X; Wang, Y; Wang, Z; Zhai, J; Zhang, G; Zhang, T; Zuo, Q, 2023)
"To compare the potential beneficial effects of the angiotensin converting enzyme inhibitor (ACEI) benazepril and the angiotensin II receptor 1 blocker (ARB) irbesartan on vaginal vascular remodeling and fibrosis in female spontaneously hypertensive rats (SHRs)."3.96Protective effects of irbesartan and benazepril against vaginal vascular remodeling and fibrosis in female spontaneously hypertensive rats. ( Li, N; Liang, W; Ma, R; Wang, Q; Yu, J; Yu, X; Zhao, X; Zhao, Y, 2020)
"Angiotensin-converting enzyme 2 (ACE2), a monocarboxypeptidase which metabolizes angiotensin II (Ang II) to generate Ang-(1-7), has been shown to prevent cardiac hypertrophy and injury but the mechanism remains elusive."3.79Cardiac protective effects of irbesartan via the PPAR-gamma signaling pathway in angiotensin-converting enzyme 2-deficient mice. ( Gao, PJ; Jin, HY; Lu, L; Oudit, GY; Penninger, JM; Shang, QH; Song, B; Xu, YL; Zhang, ZZ; Zhong, JC; Zhou, T; Zhu, DL, 2013)
"In normal mice, HS diet induces septum-predominant LVH and fibrosis through activation of the cardiac RAS-ERK pathway, which can be blocked by irbesartan or ramipril, indicating a key role of the cardiac RAS in HS diet-induced LVH."3.76The cardiac renin-angiotensin system is responsible for high-salt diet-induced left ventricular hypertrophy in mice. ( Adamy, C; Berdeaux, A; Crozatier, B; Hittinger, L; Le Corvoisier, P; Michel, JB; Sambin, L; Su, J, 2010)
"Angiotensin II (Ang II) can induce cardiac fibrosis, but the underlying mechanisms are incompletely understood."3.72Cardiac fibrosis occurs early and involves endothelin and AT-1 receptors in hypertension due to endogenous angiotensin II. ( Belloni, AS; Kreutz, R; Nussdorfer, GG; Paul, M; Pessina, AC; Rossi, GP; Seccia, TM, 2003)
"Myocardial fibrosis is a key pathological feature of HFPEF."2.76Relation of peripheral collagen markers to death and hospitalization in patients with heart failure and preserved ejection fraction: results of the I-PRESERVE collagen substudy. ( Anand, IS; Black, M; Carson, PE; Elsik, M; Komajda, M; Krum, H; Massie, BM; McKelvie, RS; McMurray, JJ; Ptaszynska, A; Schneider, HG; Zile, MR, 2011)
"Myocardial fibrosis is one of the serious pathological changes, so investigating the pathogenesis of myocardial fibrosis has the significant value."1.51Effect of Irbesartan on AGEs-RAGE and MMPs systems in rat type 2 diabetes myocardial-fibrosis model. ( Guanjun, Z; Heng, Z; Hongwei, Y; Jie, H; Jie, T; Junfeng, H; Qin, G; Ruiping, C; Xingyu, L; Yingyan, F; Zhenghong, L, 2019)
"Proteinuria was markedly attenuated in the sulodexide-treated groups."1.38Treatment of 5/6 nephrectomy rats with sulodexide: a novel therapy for chronic renal failure. ( Chen, XM; Li, P; Ma, LL; Wang, JZ; Wei, RB; Xie, RJ; Xie, YS; Yin, M, 2012)

Research

Studies (21)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's5 (23.81)29.6817
2010's12 (57.14)24.3611
2020's4 (19.05)2.80

Authors

AuthorsStudies
Wang, Z3
Zhai, J3
Zhang, T3
He, L3
Ma, S3
Zuo, Q3
Zhang, G3
Wang, Y2
Guo, Y3
Wang, X2
Ma, R1
Zhao, Y1
Yu, X1
Li, N1
Wang, Q1
Liang, W1
Zhao, X1
Yu, J1
Hongwei, Y1
Ruiping, C1
Yingyan, F1
Guanjun, Z1
Jie, H1
Xingyu, L1
Jie, T1
Zhenghong, L1
Qin, G1
Junfeng, H1
Heng, Z1
Kusunoki, H1
Taniyama, Y1
Rakugi, H1
Morishita, R1
Zhang, ZZ1
Shang, QH1
Jin, HY1
Song, B1
Oudit, GY1
Lu, L1
Zhou, T1
Xu, YL1
Gao, PJ1
Zhu, DL1
Penninger, JM1
Zhong, JC1
Chen, Q1
Pang, L1
Huang, S1
Lei, W1
Huang, D1
Kataoka, N1
Nishida, K1
Kinoshita, K1
Sakamoto, T1
Nakatani, Y1
Tsujino, Y1
Mizumaki, K1
Inoue, H1
Kinugawa, K1
Seccia, TM2
Caroccia, B1
Gioco, F1
Piazza, M1
Buccella, V1
Guidolin, D1
Guerzoni, E1
Montini, B1
Petrelli, L1
Pagnin, E1
Ravarotto, V1
Belloni, AS2
Calò, LA1
Rossi, GP2
Zhao, G1
Zhao, H1
Tu, L1
Xu, X1
Zheng, C1
Jiang, M1
Wang, P1
Wang, D1
Le Corvoisier, P1
Adamy, C1
Sambin, L1
Crozatier, B1
Berdeaux, A1
Michel, JB1
Hittinger, L1
Su, J1
Tang, RN1
Lv, LL1
Zhang, JD1
Dai, HY1
Li, Q1
Zheng, M1
Ni, J1
Ma, KL1
Liu, BC2
Krum, H1
Elsik, M1
Schneider, HG1
Ptaszynska, A1
Black, M1
Carson, PE1
Komajda, M1
Massie, BM1
McKelvie, RS1
McMurray, JJ1
Zile, MR1
Anand, IS1
Li, P1
Ma, LL1
Xie, RJ1
Xie, YS1
Wei, RB1
Yin, M1
Wang, JZ1
Chen, XM1
Marut, W1
Kavian, N1
Servettaz, A1
Hua-Huy, T1
Nicco, C1
Chéreau, C1
Weill, B1
Dinh-Xuan, AT1
Batteux, F1
Kreutz, R1
Paul, M1
Nussdorfer, GG1
Pessina, AC1
Müller-Brunotte, R1
Kahan, T1
López, B1
Edner, M1
González, A1
Díez, J1
Malmqvist, K1
Xia, HL1
Wu, JN1
Zhang, XL1
Liu, DG1
Gong, YX1
Zhou, A1
Yu, L1
Li, J1
Zhang, J1
Wang, H1
Gervais, M1
Fornes, P1
Richer, C1
Nisato, D1
Giudicelli, JF1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)[NCT00095238]Phase 34,128 participants (Actual)Interventional2002-06-30Completed
Randomized, Double-blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy[NCT00389168]Phase 2/Phase 3115 participants (Actual)Interventional1995-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14

Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14

Interventionpg/mL (Geometric Mean)
Placebo - Month 60.98
Irbesartan - Month 60.93
Placebo - Month 141.00
Irbesartan - Month 141.01

Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit

NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event. (NCT00095238)
Timeframe: Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.

,,,,,
Interventionparticipants (Number)
Month 6 - ImprovedMonth 6 - UnchangedMonth 6 - WorsenedMonth 6 - Major EventMonth 6 - No DataMonth 10 - ImprovedMonth 10 - UnchangedMonth 10 - WorsenedMonth 10 - Major EventMonth 10 - No DataMonth 14 - ImprovedMonth 14 - UnchangedMonth 14 - WorsenedMonth 14 - Major EventMonth 14 - No DataFinal Visit - ImprovedFinal Visit - UnchangedFinal Visit - WorsenedFinal Visit - Major EventFinal Visit - No Data
Irbesartan Baseline All Classes Combined9369664810107948911584110993386661751329286589732460
Irbesartan Baseline Class I or II5531041218442945310253828750222942230687511
Irbesartan Class III or IV88165678899046175318489557911531038864282924949
Placebo Baseline All Classes Combined88110165114989029397142106902890698011988269410732057
Placebo Baseline Class I or II47338472114231763914393126216164225478665
Placebo Class III or IV83467841287860622833928635787641038404402925452

Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30

Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean. (NCT00095238)
Timeframe: Baseline, Month 6, Month 18, Month 30

,,,,,
InterventionmL/min/1.73m2 (Mean)
Baseline MeanPost-Baseline MeanAdjusted Mean Change
Irbesartan - Month 1873.4968.00-5.50
Irbesartan - Month 3074.3767.05-7.12
Irbesartan - Month 673.1369.21-3.91
Placebo - Month 1873.5870.88-2.69
Placebo - Month 3073.3469.51-4.02
Placebo - Month 673.0271.97-1.07

Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66

Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean. (NCT00095238)
Timeframe: Baseline, Month 42, Month 54, Month 66

,,,,,
InterventionmL/min/1.73m2 (Mean)
Baseline MeanPost-Baseline MeanAdjusted Mean Change
Irbesartan - Month 4274.9567.48-7.36
Irbesartan - Month 5475.1768.24-6.93
Irbesartan - Month 6671.8464.85-5.46
Placebo - Month 4274.3771.34-3.14
Placebo - Month 5475.2972.65-2.63
Placebo - Month 6663.4760.09-4.91

Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit

Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure. (NCT00095238)
Timeframe: Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.

,
Interventionunits on a scale (Mean)
Baseline MeanFinal Visit Mean
Irbesartan - Final Visit38.938.3
Placebo - Final Visit42.542.6

Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14

Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14

,,,
Interventionunits on a scale (Mean)
Baseline Mean ScoreMean Score at TimepointAdjusted Mean Change from Baseline
Irbesartan - Month 1442.832.1-10.6
Irbesartan - Month 643.033.2-9.8
Placebo - Month 1442.731.6-11.2
Placebo - Month 642.732.9-10.0

Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)

Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator. (NCT00095238)
Timeframe: Baseline, Final Visit

,,,
Interventionparticipants (Number)
No prior AF history or Evidence on Baseline ECGParticipants with New Onset Atrial Fibrillation
Irbesartan + ACE-I Use36635
Irbesartan no ACE-I Use1089103
Placebo + ACE-I Use34429
Placebo no ACE-I Use110299

Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline

Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.

,
InterventionParticipants (Number)
Month 6 - Improved MarkedlyMonth 6 - Improved ModeratelyMonth 6 - Improved SlightlyMonth 6 - UnchangedMonth 6 - Worsened SlightlyMonth 6 - Worsened ModeratelyMonth 6 - Worsened MarkedlyMonth 6 - Major EventMonth 6 - No DataMonth 14 - Improved MarkedlyMonth 14 - Improved ModeratelyMonth 14 - Improved SlightlyMonth 14 - UnchangedMonth 14 - Worsened SlightlyMonth 14 - Worsened ModeratelyMonth 14 - Worsened MarkedlyMonth 14 - Major EventMonth 14 - No DataFinal Visit - Improved MarkedlyFinal Visit - Improved ModeratelyFinal Visit - Improved SlightlyFinal Visit - UnchangedFinal Visit - Worsened SlightlyFinal Visit - Worsened ModeratelyFinal Visit - Worsened MarkedlyFinal Visit - Major EventFinal Visit - No Data
Irbesartan255549512508832298121247519460476103281368153213382328460114643539576
Placebo276536501510832210711623253143050990391074146212339335461145753238478

Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline

Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.

,
InterventionParticipants (Number)
Month 6 - Improved MarkedlyMonth 6 - Improved ModeratelyMonth 6 - Improved SlightlyMonth 6 - UnchangedMonth 6 - Worsened SlightlyMonth 6 - Worsened ModeratelyMonth 6 - Worsened MarkedlyMonth 6 - Major EventMonth 6 - No DataMonth 14 - Improved MarkedlyMonth 14 - Improved ModeratelyMonth 14 - Improved SlightlyMonth 14 - UnchangedMonth 14 - Worsened SlightlyMonth 14 - Worsened ModeratelyMonth 14 - Worsened MarkedlyMonth 14 - Major EventMonth 14 - No DataFinal Visit - Improved MarkedlyFinal Visit - Improved ModeratelyFinal Visit - Improved SlightlyFinal Visit - UnchangedFinal Visit - Worsened SlightlyFinal Visit - Worsened ModeratelyFinal Visit - Worsened MarkedlyFinal Visit - Major EventFinal Visit - No Data
Irbesartan1935235045799728138122195513439525115481168153157361319479166803439576
Placebo20051947159610138137116182489443559109431674146178300337477176904238378

Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline

Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.

,
InterventionParticipants (Number)
Month 6 - Improved MarkedlyMonth 6 - Improved ModeratelyMonth 6 - Improved SlightlyMonth 6 - UnchangedMonth 6 - Worsened SlightlyMonth 6 - Worsened ModeratelyMonth 6 - Worsened MarkedlyMonth 6 - Major EventMonth 6 - No DataMonth 14 - Improved MarkedlyMonth 14 - Improved ModeratelyMonth 14 - Improved SlightlyMonth 14 - UnchangedMonth 14 - Worsened SlightlyMonth 14 - Worsened ModeratelyMonth 14 - Worsened MarkedlyMonth 14 - Major EventMonth 14 - No DataFinal Visit - Improved MarkedlyFinal Visit - Improved ModeratelyFinal Visit - Improved SlightlyFinal Visit - UnchangedFinal Visit - Worsened SlightlyFinal Visit - Worsened ModeratelyFinal Visit - Worsened MarkedlyFinal Visit - Major EventFinal Event - No Data
Irbesartan2355525295376313881222345324615037830868153207378332480121522539676
Placebo2305635195296920871162065344505278235774146201339352495109762838378

Percentage of Participants Experiencing All-cause Death at Given Time Points

Treatment comparisons for time to all-cause death (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage at 1 YearPercentage at 2 YearsPercentage at 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan4.18.112.817.925.0
Placebo3.88.613.818.523.6

Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints

Treatment comparisons for time to cardiovascular death (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage 1 YearPercentage 2 YearsPercentage 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan3.36.29.613.018.0
Placebo3.06.510.013.117.1

Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints

Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage at 1 YearPercentage at 2 YearsPercentage at 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan11.619.224.230.035.0
Placebo11.420.025.830.935.8

Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints

Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage at 1 YearPercentage at 2 YearsPercentage at 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan5.28.712.917.223.0
Placebo4.29.313.617.622.4

Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points

Treatment comparisons for time to heart failure mortality or heart failure hospitalization (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage at 1 YearPercentage at 2 YearsPercentage at 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan7.912.915.719.823.6
Placebo8.213.717.220.323.8

Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints

Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage at 1 YearPercentage at 2 YearsPercentage at 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan9.716.320.524.828.5
Placebo9.817.121.725.929.0

Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints

Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage at 1 YearPercentage at 2 YearsPercentage at 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan12.320.726.432.939.2
Placebo12.121.328.434.239.5

Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints

Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5

,
Interventionpercentage of participants (Number)
Percentage at 1 YearPercentage at 2 YearsPercentage at 3 YearsPercentage at 4 YearsPercentage at 5 Years
Irbesartan0.72.13.14.65.2
Placebo1.22.83.95.46.2

Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline

This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.

,
Interventionparticipants (Number)
Month 6 - Improved MarkedlyMonth 6 - Improved ModeratelyMonth 6 - Improved SlightlyMonth 6 - UnchangedMonth 6 - Worsened SlightlyMonth 6 - Worsened ModeratelyMonth 6 - Worsened MarkedlyMonth 6 - Major EventMonth 6 - No DataMonth 14 - Improved MarkedlyMonth 14 - Improved ModeratelyMonth 14 - Improved SlightlyMonth 14 - UnchangedMonth 14 - Worsened SlightlyMonth 14 - Worsened ModeratelyMonth 14 - Worsened MarkedlyMonth 14 - Major EventMonth 14 - No DataFinal Visit - Improved MarkedlyFinal Visit - Improved ModeratelyFinal Visit - Improved SlightlyFinal Visit - UnchangedFinal Visit - Worsened SlightlyFinal Visit - Worsened ModeratelyFinal Visit - Worsened MarkedlyFinal Visit - Major EventFinal Visit - No Data
Irbesartan2305625335286017081292145464425077221575185180430344477117412336491
Placebo1985755295415816481321955374355487319679169186367361504117562835092

Blood Pressure

Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks (NCT00389168)
Timeframe: Baseline to 48 weeks

Interventionmm Hg (Mean)
Atenolol-16.3
Irbesartan-18.8

Effects on Carotid Artery Wall Thickness

Changes in common carotid artery intima-media thickness, assessed by ultrasonography. (NCT00389168)
Timeframe: Baseline to 48 weeks

Interventionmm (Mean)
Atenolol0.03
Irbesartan-0.01

Number of Participants With Serious Adverse Events

Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication. (NCT00389168)
Timeframe: Treatment period was baseline to 48 weeks

InterventionParticipants (Number)
Atenolol5
Irbesartan5

Changes in Left Ventricular Mass Index

Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2). (NCT00389168)
Timeframe: Baseline and 48 weeks

,
Interventiong/m^2 (Mean)
12 weeks24 weeks48 weeks
Atenolol-1-6-14
Irbesartan-9-14-26

Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System

Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability. (NCT00389168)
Timeframe: Baseline to 48 weeks

,
Interventionpmol/L (Mean)
Weel 12Week 24Week 48
Atenolol-1.0-0.8-0.2
Irbesartan3.03.310.0

Left Ventricular Diastolic Function Assessed by the E/A Ratio

Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points. (NCT00389168)
Timeframe: Baseline to 48 weeks

,
Interventionratio (Mean)
Week 12Week 24Week 48
Atenolol0.180.160.13
Irbesartan0.100.040.10

Trials

2 trials available for avapro and Cirrhosis

ArticleYear
Relation of peripheral collagen markers to death and hospitalization in patients with heart failure and preserved ejection fraction: results of the I-PRESERVE collagen substudy.
    Circulation. Heart failure, 2011, Volume: 4, Issue:5

    Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Biomarkers; Biphenyl Compounds; Collagen; Double-Blin

2011
Myocardial fibrosis and diastolic dysfunction in patients with hypertension: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA).
    Journal of hypertension, 2007, Volume: 25, Issue:9

    Topics: Adrenergic beta-Antagonists; Adult; Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive

2007

Other Studies

19 other studies available for avapro and Cirrhosis

ArticleYear
Canagliflozin ameliorates epithelial-mesenchymal transition in high-salt diet-induced hypertensive renal injury through restoration of sirtuin 3 expression and the reduction of oxidative stress.
    Biochemical and biophysical research communications, 2023, 04-23, Volume: 653

    Topics: Animals; Canagliflozin; Catalase; Diet; Epithelial-Mesenchymal Transition; Fibrosis; Humans; Hyperte

2023
Canagliflozin Ameliorates Ventricular Remodeling through Apelin/Angiotensin-Converting Enzyme 2 Signaling in Heart Failure with Preserved Ejection Fraction Rats.
    Pharmacology, 2023, Volume: 108, Issue:5

    Topics: Angiotensin-Converting Enzyme 2; Animals; Apelin; Canagliflozin; Fibrosis; Heart Failure; Humans; Ir

2023
Canagliflozin and irbesartan ameliorate renal fibrosis via the TGF-β1/Smad signaling pathway in Dahl salt-sensitive rats.
    The Journal of international medical research, 2023, Volume: 51, Issue:10

    Topics: Animals; Blood Pressure; Canagliflozin; Fibrosis; Hypertension; Irbesartan; Kidney; Kidney Diseases;

2023
Protective effects of irbesartan and benazepril against vaginal vascular remodeling and fibrosis in female spontaneously hypertensive rats.
    The Journal of international medical research, 2020, Volume: 48, Issue:8

    Topics: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Animals; Benzazepines; B

2020
Effect of Irbesartan on AGEs-RAGE and MMPs systems in rat type 2 diabetes myocardial-fibrosis model.
    Experimental biology and medicine (Maywood, N.J.), 2019, Volume: 244, Issue:7

    Topics: Animals; Blood Glucose; Body Weight; Collagen; Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies;

2019
Cardiac and renal protective effects of irbesartan via peroxisome proliferator-activated receptorγ-hepatocyte growth factor pathway independent of angiotensin II Type 1a receptor blockade in mouse model of salt-sensitive hypertension.
    Journal of the American Heart Association, 2013, Apr-22, Volume: 2, Issue:2

    Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Disease Models, Animal; Epithe

2013
Cardiac protective effects of irbesartan via the PPAR-gamma signaling pathway in angiotensin-converting enzyme 2-deficient mice.
    Journal of translational medicine, 2013, Sep-25, Volume: 11

    Topics: Angiotensin I; Angiotensin II; Angiotensin-Converting Enzyme 2; Animals; Biphenyl Compounds; Cardiom

2013
Effects of emodin and irbesartan on ventricular fibrosis in Goldblatt hypertensive rats.
    Die Pharmazie, 2014, Volume: 69, Issue:5

    Topics: Angiotensin II; Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Blotting, West

2014
Effect of irbesartan on development of atrial fibrosis and atrial fibrillation in a canine atrial tachycardia model with left ventricular dysfunction, association with p53.
    Heart and vessels, 2016, Volume: 31, Issue:12

    Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Atrial Fibrillation; Atrial Remodeling; Biphenyl C

2016
Endothelin-1 Drives Epithelial-Mesenchymal Transition in Hypertensive Nephroangiosclerosis.
    Journal of the American Heart Association, 2016, 07-21, Volume: 5, Issue:7

    Topics: Actins; Angiotensin Receptor Antagonists; Animals; Animals, Genetically Modified; Biphenyl Compounds

2016
Effects and mechanism of irbesartan on tubulointerstitial fibrosis in 5/6 nephrectomized rats.
    Journal of Huazhong University of Science and Technology. Medical sciences = Hua zhong ke ji da xue xue bao. Yi xue Ying De wen ban = Huazhong keji daxue xuebao. Yixue Yingdewen ban, 2010, Volume: 30, Issue:1

    Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Fibrosis; Irbesartan; Kidney D

2010
The cardiac renin-angiotensin system is responsible for high-salt diet-induced left ventricular hypertrophy in mice.
    European journal of heart failure, 2010, Volume: 12, Issue:11

    Topics: Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Animals; Autoradi

2010
Effects of angiotensin II receptor blocker on myocardial endothelial-to-mesenchymal transition in diabetic rats.
    International journal of cardiology, 2013, Jan-10, Volume: 162, Issue:2

    Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Blotting, Western; Calcium-Bin

2013
Treatment of 5/6 nephrectomy rats with sulodexide: a novel therapy for chronic renal failure.
    Acta pharmacologica Sinica, 2012, Volume: 33, Issue:5

    Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Biomarkers; Biphenyl Compounds; Blood Pressure; Bl

2012
Amelioration of systemic fibrosis in mice by angiotensin II receptor blockade.
    Arthritis and rheumatism, 2013, Volume: 65, Issue:5

    Topics: Administration, Oral; Angiotensin II Type 1 Receptor Blockers; Animals; Biomarkers; Biphenyl Compoun

2013
Cardiac fibrosis occurs early and involves endothelin and AT-1 receptors in hypertension due to endogenous angiotensin II.
    Journal of the American College of Cardiology, 2003, Feb-19, Volume: 41, Issue:4

    Topics: Angiotensin II; Animals; Animals, Genetically Modified; Antihypertensive Agents; Biphenyl Compounds;

2003
Influence of irbesartan on expression of ILK and its relationship with epithelial-mesenchymal transition in mice with unilateral ureteral obstruction.
    Acta pharmacologica Sinica, 2007, Volume: 28, Issue:11

    Topics: Actins; Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Cadherins; Cell Transd

2007
Renal protective effects of blocking the intrarenal renin-angiotensin system: angiotensin II type I receptor antagonist compared with angiotensin-converting enzyme inhibitor.
    Hypertension research : official journal of the Japanese Society of Hypertension, 2000, Volume: 23, Issue:4

    Topics: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Animals; Biphenyl Compou

2000
Effects of angiotensin II AT1-receptor blockade on coronary dynamics, function, and structure in postischemic heart failure in rats.
    Journal of cardiovascular pharmacology, 2000, Volume: 36, Issue:3

    Topics: Angiotensin Receptor Antagonists; Animals; Biphenyl Compounds; Coronary Vessels; Dose-Response Relat

2000