Page last updated: 2024-11-07

spironolactone and Heart Failure, Diastolic

spironolactone has been researched along with Heart Failure, Diastolic in 15 studies

Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)
spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.

Heart Failure, Diastolic: Heart failure caused by abnormal myocardial relaxation during DIASTOLE leading to defective cardiac filling.

Research Excerpts

ExcerptRelevanceReference
"This study aimed to determine if variants in NR3C2, which codes the target protein of spironolactone, or CYP11B2, which is involved in aldosterone synthesis, were associated with spironolactone response, focused on the primary end point of diastolic function (E/e'), in Aldosterone Receptor Blockade in Diastolic Heart Failure (Aldo-DHF) participants."9.41NR3C2 genotype is associated with response to spironolactone in diastolic heart failure patients from the Aldo-DHF trial. ( Cavallari, LH; Duarte, JD; Dumeny, L; Edelmann, F; Pieske, B; Vardeny, O, 2021)
"This study aimed to determine if variants in NR3C2, which codes the target protein of spironolactone, or CYP11B2, which is involved in aldosterone synthesis, were associated with spironolactone response, focused on the primary end point of diastolic function (E/e'), in Aldosterone Receptor Blockade in Diastolic Heart Failure (Aldo-DHF) participants."5.41NR3C2 genotype is associated with response to spironolactone in diastolic heart failure patients from the Aldo-DHF trial. ( Cavallari, LH; Duarte, JD; Dumeny, L; Edelmann, F; Pieske, B; Vardeny, O, 2021)
"Eplerenone treatment had no significant impact on any biomarker at 6 months but attenuated the increase in pro-collagen type-III aminoterminal peptide at 12 months (p = 0."2.74Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone. ( Baugh, JA; Dawkins, IR; Ledwidge, MT; Mak, GJ; McDonald, KM; Murphy, NF; Patle, AK; Phelan, DM; Watson, CJ, 2009)
"Metabolic syndrome is a highly predisposing condition for cardiovascular disease and could be a cause of excess salt-induced organ damage."1.35Salt excess causes left ventricular diastolic dysfunction in rats with metabolic disorder. ( Ando, K; Fujita, M; Fujita, T; Kawarazaki, H; Matsui, H; Nagae, A; Nagase, M; Shimosawa, T, 2008)

Research

Studies (15)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (13.33)29.6817
2010's12 (80.00)24.3611
2020's1 (6.67)2.80

Authors

AuthorsStudies
Dumeny, L1
Vardeny, O1
Edelmann, F4
Pieske, B4
Duarte, JD1
Cavallari, LH1
Wachter, R3
Schmidt, AG2
Kraigher-Krainer, E1
Colantonio, C1
Kamke, W1
Duvinage, A1
Stahrenberg, R1
Durstewitz, K1
Löffler, M1
Düngen, HD1
Tschöpe, C1
Herrmann-Lingen, C2
Halle, M2
Hasenfuss, G2
Gelbrich, G2
Cleland, JG1
Pellicori, P1
Borlaug, BA1
Neil, CJ1
Singh, S1
Frenneaux, M1
Milan, A1
Abram, S1
Veglio, F1
Lund, LH1
Ståhlberg, M1
Voors, AA1
Hundertmark, M1
Frantz, S1
Matsui, H1
Ando, K1
Kawarazaki, H1
Nagae, A1
Fujita, M1
Shimosawa, T1
Nagase, M1
Fujita, T1
Mak, GJ1
Ledwidge, MT1
Watson, CJ1
Phelan, DM1
Dawkins, IR1
Murphy, NF1
Patle, AK1
Baugh, JA1
McDonald, KM1
Binder, L1
Einecke, D1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Characterization of Myocardial Interstitial Fibrosis and Cardiomyocyte Hypertrophy by Cardiac MRI In Heart Failure: Implication on Early Remodeling and on the Transition to Heart Failure[NCT03084679]90 participants (Anticipated)Interventional2017-11-01Recruiting
The Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart Failure[NCT00505336]43 participants (Actual)Interventional2006-04-30Completed
Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)[NCT00094302]Phase 33,445 participants (Actual)Interventional2006-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Aborted Cardiac Arrest

First incidence of aborted cardiac arrest (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo0.09
Spironolactone0.05

All-cause Mortality

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo4.6
Spironolactone4.2

Cardiovascular Mortality

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo3.1
Spironolactone2.8

Cardiovascular-related Hospitalization

Hospitalization for MI, stroke or the management of heart failure, whichever occurred first (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo6.2
Spironolactone5.5

Chloride

Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionmEq/L (Least Squares Mean)
Placebo102.33
Spironolactone102.26

Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo7.8
Spironolactone7.2

Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo6.6
Spironolactone5.9

Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo1.1
Spironolactone1.0

Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo1.1
Spironolactone1.0

Depression Symptoms, as Measured by Patient Health Questionnaire.

"Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Interventionunits on a scale (Least Squares Mean)
Placebo5.6
Spironolactone5.1

Deterioration of Renal Function

First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.) (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo2.2
Spironolactone3.2

Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.

First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo1.4
Spironolactone1.4

Estimated Glomerular Filtration Rate (GFR)

Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionmL/min/1.73m2 (Least Squares Mean)
Placebo67.50
Spironolactone65.20

Hospitalization for Any Reason

First incidence of a hospitalization for any reason (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo20.0
Spironolactone18.8

Hospitalization for the Management of Heart Failure

First incidence of a hospitalization for the management of heart failure (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo4.6
Spironolactone3.8

Myocardial Infarction

First incidence of myocardial infarction (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo1.1
Spironolactone1.2

New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.

First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo0.7
Spironolactone0.7

Potassium

Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionmEq/L (Least Squares Mean)
Placebo4.32
Spironolactone4.49

Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.

"Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.~The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition? Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Interventionunits on a scale (Least Squares Mean)
Placebo1.2
Spironolactone1.2

Quality of Life, as Measured by the EuroQOL Visual Analog Scale.

"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Interventionunits on a scale (Least Squares Mean)
Placebo65.9
Spironolactone66.4

Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.

"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Interventionunits on a scale (Least Squares Mean)
Placebo63.1
Spironolactone64.4

Serum Creatinine

Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Interventionmg/dL (Least Squares Mean)
Placebo1.11
Spironolactone1.17

Sodium

Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionmEq/L (Least Squares Mean)
Placebo140.95
Spironolactone140.33

Stroke

First incidence of stroke (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo1.1
Spironolactone1.0

Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

InterventionEvents per 100 person-years (Number)
Placebo8.3
Spironolactone6.8

Reviews

1 review available for spironolactone and Heart Failure, Diastolic

ArticleYear
[Heart failure: new insights and developments].
    Deutsche medizinische Wochenschrift (1946), 2014, Volume: 139, Issue:49

    Topics: Acute Disease; Aminobutyrates; Biphenyl Compounds; Cardiac Resynchronization Therapy; Combined Modal

2014

Trials

4 trials available for spironolactone and Heart Failure, Diastolic

ArticleYear
NR3C2 genotype is associated with response to spironolactone in diastolic heart failure patients from the Aldo-DHF trial.
    Pharmacotherapy, 2021, Volume: 41, Issue:12

    Topics: Genotype; Heart Failure, Diastolic; Humans; Receptors, Mineralocorticoid; Spironolactone; Treatment

2021
Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial.
    JAMA, 2013, Feb-27, Volume: 309, Issue:8

    Topics: Aged; Diastole; Double-Blind Method; Echocardiography; Exercise Test; Female; Heart Failure, Diastol

2013
Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone.
    Journal of the American College of Cardiology, 2009, Oct-27, Volume: 54, Issue:18

    Topics: Aged; Aged, 80 and over; Biomarkers; Collagen Type I; Collagen Type III; Echocardiography, Doppler;

2009
Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone.
    Journal of the American College of Cardiology, 2009, Oct-27, Volume: 54, Issue:18

    Topics: Aged; Aged, 80 and over; Biomarkers; Collagen Type I; Collagen Type III; Echocardiography, Doppler;

2009
Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone.
    Journal of the American College of Cardiology, 2009, Oct-27, Volume: 54, Issue:18

    Topics: Aged; Aged, 80 and over; Biomarkers; Collagen Type I; Collagen Type III; Echocardiography, Doppler;

2009
Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone.
    Journal of the American College of Cardiology, 2009, Oct-27, Volume: 54, Issue:18

    Topics: Aged; Aged, 80 and over; Biomarkers; Collagen Type I; Collagen Type III; Echocardiography, Doppler;

2009
Rationale and design of the 'aldosterone receptor blockade in diastolic heart failure' trial: a double-blind, randomized, placebo-controlled, parallel group study to determine the effects of spironolactone on exercise capacity and diastolic function in pa
    European journal of heart failure, 2010, Volume: 12, Issue:8

    Topics: Aldosterone; Diastole; Disease Progression; Diuretics; Double-Blind Method; Exercise Tolerance; Heal

2010

Other Studies

10 other studies available for spironolactone and Heart Failure, Diastolic

ArticleYear
Defining diastolic heart failure and identifying effective therapies.
    JAMA, 2013, Feb-27, Volume: 309, Issue:8

    Topics: Female; Heart Failure, Diastolic; Humans; Male; Mineralocorticoid Receptor Antagonists; Spironolacto

2013
Spironolactone made no difference to patients with mild diastolic heart failure.
    BMJ (Clinical research ed.), 2013, Feb-27, Volume: 346

    Topics: Controlled Clinical Trials as Topic; Diuretics; Heart Failure, Diastolic; Humans; Mineralocorticoid

2013
Heart failure: Aldosterone antagonism for HFpEF.
    Nature reviews. Cardiology, 2013, Volume: 10, Issue:5

    Topics: Biomarkers; Cardiovascular Agents; Heart Failure, Diastolic; Humans; Mineralocorticoid Receptor Anta

2013
Aldosterone inhibition in patients with heart failure with preserved ejection fraction.
    JAMA, 2013, Jul-10, Volume: 310, Issue:2

    Topics: Female; Heart Failure, Diastolic; Humans; Male; Mineralocorticoid Receptor Antagonists; Spironolacto

2013
Aldosterone inhibition in patients with heart failure with preserved ejection fraction.
    JAMA, 2013, Jul-10, Volume: 310, Issue:2

    Topics: Female; Heart Failure, Diastolic; Humans; Male; Mineralocorticoid Receptor Antagonists; Spironolacto

2013
Aldosterone inhibition in patients with heart failure with preserved ejection fraction.
    JAMA, 2013, Jul-10, Volume: 310, Issue:2

    Topics: Female; Heart Failure, Diastolic; Humans; Male; Mineralocorticoid Receptor Antagonists; Spironolacto

2013
Aldosterone inhibition in patients with heart failure with preserved ejection fraction--reply.
    JAMA, 2013, Jul-10, Volume: 310, Issue:2

    Topics: Female; Heart Failure, Diastolic; Humans; Male; Mineralocorticoid Receptor Antagonists; Spironolacto

2013
[Spironolactone not effective in diastolic heart failure].
    Nederlands tijdschrift voor geneeskunde, 2014, Volume: 158

    Topics: Heart Failure, Diastolic; Hospitalization; Humans; Mineralocorticoid Receptor Antagonists; Spironola

2014
Salt excess causes left ventricular diastolic dysfunction in rats with metabolic disorder.
    Hypertension (Dallas, Tex. : 1979), 2008, Volume: 52, Issue:2

    Topics: Aldosterone; Animals; Blood Pressure Determination; Disease Models, Animal; Echocardiography, Dopple

2008
[2 promising substances for diastolic heart failure].
    MMW Fortschritte der Medizin, 2012, Sep-10, Volume: 154, Issue:15

    Topics: Aminobutyrates; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; B

2012