Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

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 of care.

Key facts

Study ID

NCT02235077

Run by

Duke University

People needed

360

Starts

2014-12-30

Expected to finish

2016-06-06

Last updated by the study team

2017-06-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston VA Healtcare System — West Roxbury, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Duke University — Durham, North Carolina, United States
• Southeastern Regional Medical Center — Lumberton, North Carolina, United States
• University Hospitals - Case Medical Center — Cleveland, Ohio, United States
• Metro Health System — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Jefferson Medical College — Philadelphia, Pennsylvania, United States
• Michael Debakey VA Medical Center — Houston, Texas, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Utah VA Medical Center — Salt Lake City, Utah, United States
• The University of Vermont- Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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