CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Inhaled Nitritedrug
Likely dose
Inhaled Nitrite 45 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/NCT01431313
NCT01431313Phase 2Completed
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A Dose Escalation Study to Evaluate the Effect of Inhaled Nitrite on Cardiopulmonary Hemodynamics in Subjects With Pulmonary Hypertension

Schmidhofer, Mark, MD·interventional·Posted Sep 9, 2011·Updated Mar 28, 2019

In Brief

A Phase 2 clinical trial evaluating Inhaled Nitrite for Pulmonary Hypertension and Heart Failure, Diastolic. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This is a single-center, open label phase II study to evaluate the effect of inhaled nitrite delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in subjects with pulmonary hypertension undergoing right heart catheterization. A total of 50 subjects with a confirmed diagnosis of pulmonary hypertension and meet all inclusion/exclusion criteria will be enrolled in the study which will entail a single right heart catheterization and nebulized nitrite dose of 45mg with one subsequent dosage of 90 mg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension, Heart Failure, Diastolic
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartJun 1, 2012
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 14.8 years ago

Interventions

Inhaled Nitritedrug

Each patient will receive a starting dose of 45 mg of inhaled nitrite, with one planned subsequent planned dose of 90 mg of inhaled nitrite