CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Sodium Nitrite +1 moredrug
Likely dose
Sodium Nitrite 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03015402
NCT03015402Phase 2Completed
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Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

University of Pittsburgh·interventional·Posted Jan 10, 2017·Updated Jun 7, 2024

In Brief

A Phase 2 clinical trial evaluating Sodium Nitrite and Placebo Oral Capsule for Pulmonary Hypertension Secondary and Heart Failure. Completed, enrolled 33 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension Secondary, Heart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 10, 2017
Enrollment StartOct 30, 2017
Primary CompletionJan 25, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.5 years ago

Interventions

Sodium Nitritedrug

40 mg PO (by mouth) TID (three times each day) for 10 weeks

Placebo Oral Capsuledrug

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