Status:
COMPLETED
Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard...
Detailed Description
Mineralocorticoid receptor antagonist (MRA) therapy is recommended in stable chronic systolic heart failure (HF) and post-infarction HF patients for improving morbidity and mortality. MRA therapy in A...
Eligibility Criteria
Inclusion
- Male or female patient ≥21 years old
- Admitted to hospital for AHF with at least 1 symptom (dyspnea, orthopnea, or fatigue) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) of congestion
- Patient must be randomized within 24 hours of first IV diuretic dose administered for the current episode of decompensation (regardless of where the diuretic was given e.g. office, ED, ambulance, hospital etc.)
- Estimated GFR of ≥30 mL/min/1.73m2 determined by the MDRD equation
- Serum K+ ≤5.0 mmol/L at enrollment
- NT-proBNP ≥1000 pg/mL or BNP ≥250 pg/mL, measured within 24h from randomization
- Not on MRA or on low-dose spironolactone (12.5 mg or 25 mg daily) at baseline
Exclusion
- Taking eplerenone or \>25 mg spironolactone at baseline
- eGFR \< 30 ml/min/1.73m2
- Serum K+ \>5.0 mmol/L. If a repeat measurement within the enrollment window is \<5.0, the patient can be considered for inclusion.
- Systolic blood pressure \<90 mmHg
- Hemodynamically significant arrhythmias or defibrillator shock within 1 week
- Acute coronary syndrome currently suspected or within the past 4 weeks
- Severe liver disease (ALT or AST \>3 x normal, alkaline phosphatase or bilirubin \>2x normal)
- Active infection (current use of oral or IV antimicrobial agents)
- Active gastrointestinal bleeding
- Active malignancy other than non-melanoma skin cancers
- Current or planned mechanical circulatory support within 30 days
- Post cardiac transplant or listed for transplant and expected to receive one within 30 days
- Current inotrope use
- Complex congenital heart disease
- Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
- Previous adverse reaction to MRAs
- Enrollment in another randomized clinical trial during index hospitalization
Key Trial Info
Start Date :
December 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2016
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02235077
Start Date
December 30 2014
End Date
June 6 2016
Last Update
June 14 2017
Active Locations (22)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114