Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF

PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

August 10, 2016

Primary Completion Date

December 13, 2017

Study Completion Date

December 27, 2017

Conditions
Heart Failure
Interventions
DRUG

Nebulized Sodium Nitrite

Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.

DRUG

Placebo

Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.

Trial Locations (20)

11794

Stony Brook University Medical Center, Stony Brook

19001

Abington Memorial Hospital, Abington

19104

University of Pennsylvania Health System, Philadelphia

19107

Jefferson Medical College, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

27705

Duke University Medical Center, Durham

30322

Emory University School of Medicine, Atlanta

44106

University Hospitals Cleveland Medical Center, Cleveland

44109

Metro Health System, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

55905

Mayo Clinic, Rochester

60611

Northwestern University, Chicago

63106

V.A St. Louis Health Care System, St Louis

63110

Washington University School of Medicine, St Louis

65212

University of Missouri Health System, Columbia

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

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Aires Pharmaceuticals, Inc.

INDUSTRY

collaborator

University of Vermont

OTHER

collaborator

Université de Montréal

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

Massachusetts General Hospital

OTHER

lead

Adrian Hernandez

OTHER