amlodipine and Endomyocardial Fibrosis studies

Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina.

Endomyocardial Fibrosis: A condition characterized by the thickening of the ventricular ENDOCARDIUM and subendocardium (MYOCARDIUM), seen mostly in children and young adults in the TROPICAL CLIMATE. The fibrous tissue extends from the apex toward and often involves the HEART VALVES causing restrictive blood flow into the respective ventricles (CARDIOMYOPATHY, RESTRICTIVE).

Research Excerpts

Excerpt	Relevance	Reference
"Azelnidipine suppressed cardiac hypertrophy, fibrosis, NADPH oxidase and superoxide in spSHRs more potently than amlodipine, and was associated with lower heart rates than amlodipine."	3.73	Enhancement of cardiac oxidative stress by tachycardia and its critical role in cardiac hypertrophy and fibrosis. ( Ito, T; Kataoka, K; Kim-Mitsuyama, S; Lai, ZF; Ogawa, H; Tanaka, T; Tokutomi, Y; Yamamoto, E; Yamashita, T, 2006)
"Our objective was to examine the effect of chronic treatment with amlodipine on blood pressure, left ventricular hypertrophy, and fibrosis in spontaneously hypertensive rats and the persistence of such an effect after drug withdrawal."	3.72	Amlodipine decreases fibrosis and cardiac hypertrophy in spontaneously hypertensive rats: persistent effects after withdrawal. ( Ardanaz, N; Arévalo, MA; Carrón, R; Guerrero, EI; Montero, MJ; San Román, L; Sevilla, MA; Voces, F, 2004)
"In losartan-treated patients, CVF decreased from 5."	2.70	Usefulness of serum carboxy-terminal propeptide of procollagen type I in assessment of the cardioreparative ability of antihypertensive treatment in hypertensive patients. ( Díez, J; González, A; Larman, M; López, B; Martínez Ubago, JL; Querejeta, R; Varo, N, 2001)

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Left Ventricular Ejection Fraction

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	3 (100.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Sevilla, MA	1
Voces, F	1
Carrón, R	1
Guerrero, EI	1
Ardanaz, N	1
San Román, L	1
Arévalo, MA	1
Montero, MJ	1
Yamamoto, E	1
Lai, ZF	1
Yamashita, T	1
Tanaka, T	1
Kataoka, K	1
Tokutomi, Y	1
Ito, T	1
Ogawa, H	1
Kim-Mitsuyama, S	1
López, B	1
Querejeta, R	1
Varo, N	1
González, A	1
Larman, M	1
Martínez Ubago, JL	1
Díez, J	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)[NCT01052428]	Phase 2/Phase 3	38 participants (Actual)	Interventional	2004-08-31	Completed
Phase 2/3 Study of Effect of AT1RB Versus ACE Inhibitor in Addition to XO Inhibitor on Progression of LV Remodeling and Dysfunction in Diabetic Patients With Acute MI.[NCT01052272]	Phase 2/Phase 3	72 participants (Actual)	Interventional	2005-07-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Left Ventricular Ejection Fraction Is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal. (NCT01052428)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End Diastolic Volume Indexed to Body Surface Area

Intervention	percent (Mean)
	Month 0 (n=19,19)	Month 3 (n=1,0)	Month 6 (n=17,19)	Month 9 (n=1,1)	Month 12 (n=14,15)	Month 15 (n=3,2)	Month 18 (n=14,18)	Month 21 (n=5,0)	Month 24 (n=16,18)
Placebo	62.62	63.90	63.80	41.90	61.70	44.70	60.95	53.79	59.95
Toprol XL	62.09	NA	61.29	54.81	62.77	68.47	62.05	NA	63.02

Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. (NCT01052428)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End Systolic Volume Indexed to Body Surface Area

Intervention	ml/m^2 (Mean)
	Month 0 (n=19,19)	Month 3 (n=1,0)	Month 6 (n=17,19)	Month 9 (n=1,0)	Month 12 (n=14,15)	Month 15 (n=3,2)	Month 18 (n=14,18)	Month 21 (n=5,0)	Month 24 (n=16,18)
Placebo	91.66	90.93	90.84	70.56	88.99	82.73	90.16	85.75	87.31
Toprol XL	95.74	NA	95.24	NA	95.71	98.16	97.6	NA	95.16

Left Ventricular End Systolic Volume Indexed to Body Surface Area As an indicator of heart size, the blood volume of the heart is related to the body size. The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. (NCT01052428)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume

Intervention	ml/m^2 (Mean)
	Month 0 (n=19,19)	Month 3 (n=1,0)	Month 6 (n=17,19)	Month 9 (n=1,0)	Month 12 (n=14,15)	Month 15 (n=3,2)	Month 18 (n=14,18)	Month 21 (n=5,0)	Month 24 (n=16,18)
Placebo	34.01	32.83	32.53	40.99	33.70	47.25	34.99	39.97	34.47
Toprol XL	35.98	NA	36.53	NA	35.89	30.97	36.72	NA	35.13

Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. (NCT01052428)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-Diastolic Radius to Wall Thickness

Intervention	g/ml (Mean)
	Month 0 (n=19,19)	Month 3 (n=1,0)	Month 6 (n=17,19)	Month 9 (n=1,1)	Month 12 (n=14,15)	Month 15 (n=3,2)	Month 18 (n=14,18)	Month 21 (n=5,0)	Month 24 (n=16,18)
Placebo	0.61	0.53	0.62	0.67	0.65	0.65	0.65	0.61	0.64
Toprol XL	0.61	NA	0.6	0.53	0.60	0.55	0.59	NA	0.62

Left Ventricular End-Diastolic Radius to Wall Thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. (NCT01052428)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Peak Early Filling Rate: Rate of Change Over Time

Intervention	unitless (Mean)
	Month 0 (n=19,19)	Month 3 (n=1,0)	Month 6 (n=17,19)	Month 9 (n=1,1)	Month 12 (n=14,15)	Month 15 (n=3,2)	Month 18 (n=14,18)	Month 21 (n=5,0)	Month 24 (n=16,18)
Placebo	4.76	5.02	4.51	4.15	4.46	4.61	4.43	4.72	4.52
Toprol XL	4.69	NA	4.85	5.74	4.79	5.02	4.77	NA	4.59

Peak Early Filling Rate The peak early filling rate of change is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle. (NCT01052428)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Systolic Longitudinal Strain

Intervention	EDV/sec (Mean)
	Month 0 (n=19,19)	Month 3 (n=1,0)	Month 6 (n=17,19)	Month 9 (n=1,0)	Month 12 (n=14,15)	Month 15 (n=3,2)	Month 18 (n=14,18)	Month 21 (n=5,0)	Month 24 (n=16,18)
Placebo	2.27	2.58	2.38	1.56	2.26	1.83	1.95	1.73	2.17
Toprol XL	2.12	NA	2.08	NA	2.24	2.28	2.26	NA	2.25

Systolic Longitudinal Strain. By identifying two points on the heart, the strain is the difference between the distance between these two points at the end of filling of the heart and the end of contraction divided by the length at the end of filling. Thus, the measure is like the ejection fraction, however the strain is more localized to a specified segment in the heart muscle. The higher values indicate a healthy heart. (NCT01052428)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular Ejection Fraction (LVEF)

Intervention	percent/%Systolic interval (Mean)
	Month 0 (n=19,19)	Month 3 (n=1,0)	Month 6 (n=17,19)	Month 9 (n=1,0)	Month 12 (n=14,15)	Month 15 (n=3,2)	Month 18 (n=14,18)	Month 21 (n=5,0)	Month 24 (n=16,18)
Placebo	87.94	115.07	45.90	37.2	87.85	52.95	88.11	67.53	79.94
Toprol XL	82.55	NA	78.68	NA	80.04	88.34	79.29	NA	85.18

LVEF is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes (NCT01052272)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)

Intervention	percent (Mean)
	Month 0 (n=17,17,18,18)	Month 6(n=14,11,11,12)	Month 9(n=1,2,0,0)	Month 12(n=12,11,11,11)	Month 15(n=3,2,1,1)	Month 18(n=10,12,8,8)	Month 21(n=3,0,0,1)	Month 24 (n=11,9,8,10)	Month 27 (n=1,1,0,1)
Candesartan Cilexetil	56.36	56.82	42.62	52.37	39.88	56.33	NA	51.70	54.17
Candesartan Cilexetil and Allopurinol	52.68	57.28	NA	56.11	54.46	57.82	56.17	55.79	54.40
Ramipril	52.19	54.20	64.98	52.76	52.13	55.02	51.27	57.18	50.73
Ramipril and Allopurinol	53.37	52.80	NA	51.74	34.89	54.05	NA	55.59	NA

LVEDV/BSA: As an indicator of heart size, the blood volume of the heart is related to the body size. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals. (NCT01052272)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)

Intervention	ml/m^2 (Mean)
	Month 0 (n=17,17,18,18)	Month 6(n=14,11,11,12)	Month 9(n=1,2,0,0)	Month12(n=12,11,11,11)	Month 15(n=3,2,1,1)	Month 18(n=10,12,8,8)	Month 21(n=3,0,0,1)	Month 24 (n=11,9,8,10)	Month 27 (n=1,1,0,1)
Candesartan Cilexetil	78.06	78.60	93.57	85.44	90.20	82.74	NA	84.28	76.65
Candesartan Cilexetil and Allopurinol	79.03	78.01	NA	79.75	63.1	84.95	75.27	79.72	75.05
Ramipril	73.03	74.10	73.23	75.34	81.19	75.28	71.99	70.46	48.68
Ramipril and Allopurinol	78.52	86.13	NA	83.95	108.25	67.96	NA	71.63	NA

LVESV/BSA: The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals. (NCT01052272)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)

Intervention	ml/m^2 (Mean)
	Month 0 (n=17,17,18,18)	Month 6(n=14,11,11,12)	Month 9(n=1,2,0,0)	Month 12(n=12,11,11,11)	Month 15(n=3,2,1,1)	Month 18(n=10,12,8,8)	Month 21(n=3,0,0,1)	Month 24 (n=11,9,8,10)	Month 27 (n=1,1,0,1)
Candesartan Cilexetil	35.26	35.26	53.87	42.27	54.04	37.76	NA	41.72	35.13
Candesartan Cilexetil and Allopurinol	39.49	34.15	NA	36.07	28.74	37.18	32.99	35.99	34.22
Ramipril	36.20	34.77	25.64	36.82	39.42	35.30	35.23	31.17	23.98
Ramipril and Allopurinol	37.91	42.88	NA	42.34	70.48	30.39	NA	31.56	NA

LVED Mass/LVEDV: As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. (NCT01052272)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)

Intervention	g/ml (Mean)
	Month 0 (n=17,17,18,18)	Month 6(n=14,11,11,12)	Month 9(n=1,2,0,0)	Month 12(n=12,11,11,11)	Month 15(n=3,2,1,1)	Month 18(n=10,12,8,8)	Month 21(n=3,0,0,1)	Month 24 (n=11,9,8,10)	Month 27 (n=1,1,0,1)
Candesartan Cilexetil	0.95	0.83	0.67	0.78	0.70	0.79	NA	0.80	0.64
Candesartan Cilexetil and Allopurinol	0.87	0.82	NA	0.86	0.68	0.80	0.69	0.82	0.69
Ramipril	0.92	0.87	0.75	0.84	0.81	0.79	0.95	0.84	0.93
Ramipril and Allopurinol	0.86	0.71	NA	0.72	0.57	0.83	NA	0.80	NA

LVED Radius/Wall thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. (NCT01052272)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

LV End Systolic Maximum Shortening (LVES Max Shortening)

Intervention	unitless (Mean)
	Month 0 (n=17,17,18,18)	Month 6(n=14,11,11,12)	Month 9(n=1,2,0,0)	Month 12(n=12,11,11,11)	Month 15(n=3,2,1,1)	Month 18(n=10,12,8,8)	Month 21(n=3,0,0,1)	Month 24 (n=11,9,8,10)	Month 27 (n=1,1,0,1)
Candesartan Cilexetil	3.14	3.39	4.14	3.68	4.10	3.71	NA	3.58	4.04
Candesartan Cilexetil and Allopurinol	3.45	3.63	NA	3.42	3.90	3.56	4.24	3.56	4.29
Ramipril	3.23	3.32	3.42	3.43	3.44	3.60	2.92	3.46	3.12
Ramipril and Allopurinol	3.57	4.04	NA	4.01	4.57	3.60	NA	3.61	NA

By identifying three points in three different planes in the heart muscle, the maximum shortening is the average of the difference between the distance between these three points at the end of filling of the heart and the end of contraction divided by the length at the end of filling times 100. The maximum shortening is a three dimensional analysis. The higher values indicate a healthy heart. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. (NCT01052272)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Peak Early Filling Rate Normalized to EDV

Intervention	percent of length at end of filling (Mean)
	Month 0 (n=17,17,17,18)	Month 6(n=14,11,10,12)	Month 9(n=1,2,0,0)	Month 12(n=11,11,10,10)	Month 15(n=3,2,1,1)	Month 18(n=10,12,7,8)	Month 21(n=3,0,0,1)	Month 24 (n=11,9,8,10)	Month 27 (n=1,1,0,1)
Candesartan Cilexetil	16.68	17.50	19.08	17.13	16.28	17.55	NA	16.62	20.38
Candesartan Cilexetil and Allopurinol	16.00	18.50	NA	18.51	16.36	17.52	17.89	17.85	16.59
Ramipril	15.81	16.88	18.43	14.57	17.06	17.26	16.68	15.67	13.70
Ramipril and Allopurinol	15.84	18.72	NA	17.96	14.22	17.46	NA	17.52	NA

The Peak Early Filling Rate Normalized to EDV is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. (NCT01052272)
Timeframe: 5 visits per Participant over 2 years (about every 6 months)

Article	Year
Usefulness of serum carboxy-terminal propeptide of procollagen type I in assessment of the cardioreparative ability of antihypertensive treatment in hypertensive patients. Circulation, 2001, Jul-17, Volume: 104, Issue:3 Topics: Adult; Aged; Amlodipine; Angiotensin Receptor Antagonists; Antihypertensive Agents; Biopsy; Blood Pr	2001
Usefulness of serum carboxy-terminal propeptide of procollagen type I in assessment of the cardioreparative ability of antihypertensive treatment in hypertensive patients. Circulation, 2001, Jul-17, Volume: 104, Issue:3 Topics: Adult; Aged; Amlodipine; Angiotensin Receptor Antagonists; Antihypertensive Agents; Biopsy; Blood Pr	2001
Usefulness of serum carboxy-terminal propeptide of procollagen type I in assessment of the cardioreparative ability of antihypertensive treatment in hypertensive patients. Circulation, 2001, Jul-17, Volume: 104, Issue:3 Topics: Adult; Aged; Amlodipine; Angiotensin Receptor Antagonists; Antihypertensive Agents; Biopsy; Blood Pr	2001
Usefulness of serum carboxy-terminal propeptide of procollagen type I in assessment of the cardioreparative ability of antihypertensive treatment in hypertensive patients. Circulation, 2001, Jul-17, Volume: 104, Issue:3 Topics: Adult; Aged; Amlodipine; Angiotensin Receptor Antagonists; Antihypertensive Agents; Biopsy; Blood Pr	2001

Article	Year
Amlodipine decreases fibrosis and cardiac hypertrophy in spontaneously hypertensive rats: persistent effects after withdrawal. Life sciences, 2004, Jul-02, Volume: 75, Issue:7 Topics: Amlodipine; Animals; Antihypertensive Agents; Blood Pressure; Disease Models, Animal; Dose-Response	2004
Enhancement of cardiac oxidative stress by tachycardia and its critical role in cardiac hypertrophy and fibrosis. Journal of hypertension, 2006, Volume: 24, Issue:10 Topics: Amlodipine; Animals; Azetidinecarboxylic Acid; Cardiomegaly; Dihydropyridines; Endomyocardial Fibros	2006

amlodipine and Endomyocardial Fibrosis