At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 105 enrolled

Drug / intervention

Nebulized Sodium Nitrite +1 moredrug

Likely dose

Nebulized Sodium Nitrite 80 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/NCT02742129

NCT02742129Phase 2Completed

Compare CT.gov

Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF

Adrian Hernandez·interventional·Posted Apr 18, 2016·Updated Mar 13, 2019

In Brief

A Phase 2 clinical trial evaluating Nebulized Sodium Nitrite and Placebo for Heart Failure. Completed, enrolled 105 participants across 20 sites.

Detailed Summary

A randomized, double-blind, placebo-controlled crossover study to assess the effect of inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing. Approximately 100 participants will be enrolled in this 2\*2 crossover study.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHeart Failure

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Aires Pharmaceuticals, Inc., University of Vermont, Université de Montréal, Mayo Clinic, Massachusetts General Hospital

Timeline

Phase 2CompletedFinished

2017201820192020202120222023202420252026

First PostedApr 2016

Enrollment StartAug 2016

Primary CompletionDec 2017

Study CompletionDec 2017

TodayJul 2026

First PostedApr 18, 2016

Enrollment StartAug 10, 2016

Primary CompletionDec 13, 2017

Study CompletionDec 27, 2017

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 10.2 years ago

Interventions

Nebulized Sodium Nitritedrug

Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.

Placebodrug

Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.