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

PHASE2CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

December 30, 2014

Primary Completion Date

April 12, 2016

Study Completion Date

June 6, 2016

Conditions
Heart Failure
Interventions
DRUG

Spironolactone

"Patients receiving no MRA at home will receive spironolactone 100 mg (4x25 mg capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will be randomized to receive spironolactone 25 mg (1x25 mg capsules) or 100 mg (4x25 mg capsules) in hospital for 96 hours. The patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding."

DRUG

Placebo

"Patients receiving no MRA at home will receive 100 mg placebo (4x25 mg capsules) once daily for 96 hours.~Patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding."

Trial Locations (22)

11794

Stony Brook University Medical Center, Stony Brook

17603

Lancaster General Hospital, Lancaster

19104

University of Pennsylvania, Philadelphia

19107

Jefferson Medical College, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

27705

Duke University, Durham

28358

Southeastern Regional Medical Center, Lumberton

30322

Emory University School of Medicine, Atlanta

44106

University Hospitals - Case Medical Center, Cleveland

44109

Metro Health System, Cleveland

44195

Cleveland Clinic, Cleveland

55905

Mayo Clinic, Rochester

63110

Washington University, St Louis

63117

Saint Louis University Hospital, St Louis

77030

Michael Debakey VA Medical Center, Houston

84132

University of Utah School of Medicine, Salt Lake City

Utah VA Medical Center, Salt Lake City

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02132

Boston VA Healtcare System, West Roxbury

05401

The University of Vermont- Fletcher Allen Health Care, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Duke University

OTHER

NCT02235077 - Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure | Biotech Hunter | Biotech Hunter