CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
14 N Sodium Nitritedrug
Likely dose
14 N 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/NCT02457260
NCT02457260Phase 2Completed
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Study of the Utility of Oral Nitrite Therapy to Improve Skeletal Muscle Bioenergetics and Physical Capacity in Older Heart Failure Patients

Gladwin, Mark, MD·interventional·Posted May 29, 2015·Updated Sep 18, 2018

In Brief

A Phase 2 clinical trial evaluating 14 N Sodium Nitrite for Heart Failure. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational new drug (IND) approved sodium nitrite (10 milligram \[mg\]) capsule, and its utility to upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP) pathway of skeletal muscle of younger heart failure (HF) patients. It now seems exceptionally logical and opportune to apply these insights to older HF patients and to delineate mechanisms of disease and aging that respond to nitrite therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 29, 2015
Enrollment StartJan 8, 2016
Primary CompletionMar 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.1 years ago

Interventions

14 N Sodium Nitritedrug

oral formulation of sodium nitrite 40 mg three times daily for 4 weeks