CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
sodium nitrite +1 moredrug
Likely dose
Not stated in 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/NCT02918552
NCT02918552Phase 2Completed
CompareCT.gov

Nitrite Benefits to Mediate Fatigability in Older HFpEF Patients

Gladwin, Mark, MD·interventional·Posted Sep 29, 2016·Updated Jan 22, 2020

In Brief

A Phase 2 clinical trial evaluating sodium nitrite and Control for Heart Failure. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle bioenergetics, serology including inflammatory markers and platelet bioenergetics, quality of life measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 29, 2016
Enrollment StartApr 3, 2017
Primary CompletionDec 2, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.8 years ago

Interventions

sodium nitritedrug

Subjects to receive active study drug three times daily during treatment period and then post treatment testing period.

Controldrug

Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period.