Phase 3
N=20
Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02585843 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Change in Body Weight — -1.9; -1.9 kilogram
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Spironolactone 100mg (Drug); Spironolactone 25mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
-1.9; -1.9 | — |
| SECONDARY Change in Estimated Jugular Venous Pressure (cmH2O) |
-3.2; -3.9 | — |
| SECONDARY Change in 6-minute Walk Test Distance (6MWT) |
36; 36 | — |
| SECONDARY Change in Score on the Visual Analogue Scale (VAS) |
26; 25 | — |
| SECONDARY Change From Baseline to Day 7 on the Seven-Level Likert Scale |
2.1; 2.6 | — |
Summary
This is a prospective, single-center, double-blind and randomized placebo controlled trial for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution of signs and symptoms of congestion in outpatients with acute decompensated heart failure (ADHF). Patients who are not responding to their current loop diuretics will be considered for this study. Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of care in management of heart failure (HF) patients. However, recommended doses of MRAs (spironolactone 25mg/daily or eplerenone 50mg/daily) will not have any impact on signs and symptoms of volume overload. Therefore, the proposed study will aim to show the impact of this outpatient regimen to improve diuresis and possible reduction in hospitalization for further diuretic management in HF patients with signs and symptoms of congestion.
Eligibility Criteria
Inclusion Criteria
- History of heart failure with either reduced or preserved ejection fraction for 3 months
- Patients with New York Heart Association (NYHA) class II- IV heart failure symptoms, with at least one worsening symptom (Dyspnea on exertion, shortness of breath, orthopnea, early satiety) and one sign of congestion (pulmonary rales, elevated jugular venous pressure10cmHg, peripheral edema and ascites)
- Decision by primary cardiologist or heart failure (HF) specialist to increase the home diuretic dose
- Stable treatment with beta-blockers for 1 month unless contraindicated (i.e. intolerance, bradycardia) as specified by primary cardiologist/HF provider
- Stable treatment with angiotensin converting enzyme-1 (ACE-1) or angiotensin receptor blocker (ARB) for 1 month
- Spironolactone dose 25mg or eplerenone 50mg per day
- Daily furosemide or furosemide equivalent dose of 80mg or greater
- Serum potassium concentration 4.5 mmol/L or 5.0 mmol/L if on potassium supplements
- Estimated Glomerular Filtration Rate (eGFR) by Modification of Diet in Renal Disease (MDRD) equation 40 ml/min/1.73
Exclusion Criteria
- Inability to complete informed consent form
- Allergy or intolerance to spironolactone
- Systolic blood pressure <100 mmHg
- Patient in need of hospitalization per cardiologist decision
- Current inotrope dependency
- Current mechanical circulatory support
- Acute coronary syndromes or unstable angina within the past 4 weeks
- History of cardiac transplant
- Obstructive cardiac valvular disease
- Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy
- Significant ventricular arrhythmia necessitating defibrillator therapy within the past 14 days
- Atrioventricular conduction abnormality greater than first-degree block
- Primary liver disease resulted in cirrhosis or abnormal liver function tests (transaminases and alkaline phosphatase levels 3 times the upper limit of normal
- Acute malignancy
- Active infection requiring antimicrobial treatment (Suppression antimicrobial for chronic infections are exempt)
Data sourced from ClinicalTrials.gov (NCT02585843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.