NCT03015402

Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.

Conditions

• Pulmonary Hypertension Secondary
• Heart Failure

Interventions

Type	Name	Description
DRUG	Sodium Nitrite	40 mg PO (by mouth) TID (three times each day) for 10 weeks
DRUG	Placebo Oral Capsule	Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 10 weeks

Timeline

• Start date: 2017-10-30
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2017-01-10
• Last updated: 2024-06-07
• Results posted: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study