CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Sodium Nitrite Inhalation Solution +1 moredrug
Likely dose
Sodium Nitrite Inhalation Solution 90mgfrom 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/NCT02262078
NCT02262078Phase 2Completed
CompareCT.gov

Acute Effects of Inhaled Sodium Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

Mayo Clinic·interventional·Posted Oct 10, 2014·Updated Aug 29, 2017

In Brief

A Phase 2 clinical trial evaluating Sodium Nitrite Inhalation Solution and Placebo for Heart Failure. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of nebulized inhaled nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsAires Pharmaceuticals, Inc., National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 10, 2014
Enrollment StartOct 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.7 years ago

Interventions

Sodium Nitrite Inhalation Solutiondrug

90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.

Placeboother

Normal saline will be administered (by inhalation) to participants prior to exercise.