Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

March 31, 2015

Conditions
Heart Failure
Interventions
DRUG

Isosorbide Mononitrate

"Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"

DRUG

Placebo

"Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"

Trial Locations (22)

17604

Lancaster General Hospital, Lancaster

19104

University of Pennsylvania Health System, Philadelphia

19107

Jefferson Medical College, Philadelphia

19140

Temple University Hospital, Philadelphia

19718

Christiana Care Health Services, Newark

21287

Johns Hopkins Hospital, Baltimore

27705

Duke University Medical Center, Durham

30322

Emory University School of Medicine, Atlanta

44106

University Hospitals Case Medical Center, Cleveland

44109

Metro Health System, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

55905

Mayo Clinic, Rochester

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

77030

Michael E Debakey VA Medical Center, Houston

84132

University of Utah Hospitals and Clinics, Salt Lake City

84148

V.A. Medical Center, Salt Lake City

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02132

Boston V.A. Healthcare System, West Roxbury

05401

The University of Vermont - Fletcher Allen Health Care, Burlington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Mayo Clinic

OTHER

collaborator

University of Vermont

OTHER

lead

Adrian Hernandez

OTHER