Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
Who is this study for? Patients with Heart Failure
What treatments are being studied? Sodium Nitrite
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Age 18 years and older
⁃ PH-HFpEF confirmed diagnosis by RHC:
• Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND
• Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND
• Transpulmonary Gradient (TPG) ≥ 12 mmHg
Locations
United States
Pennsylvania
University of Pittsburgh
Pittsburgh
Time Frame
Start Date: 2017-10-30
Completion Date: 2023-01-25
Participants
Target number of participants: 33
Treatments
Experimental: Sodium Nitrite
Study
Placebo_comparator: Placebo
Control
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Pittsburgh
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)