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Completed Phase 2 Interventional Accepts healthy volunteers Results available

Oral Nitrite for Older Heart Failure Patients

ClinicalTrials.gov ID: NCT02457260

Public ClinicalTrials.gov record NCT02457260. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 4:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Study of the Utility of Oral Nitrite Therapy to Improve Skeletal Muscle Bioenergetics and Physical Capacity in Older Heart Failure Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02457260
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Gladwin, Mark, MD
Individual
Enrollment
21 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
70 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 7, 2016
Primary completion
Mar 5, 2017
Completion
Mar 5, 2017
Last update posted
Sep 17, 2018

2016 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UPMC Montefiore Hospital Pittsburgh Pennsylvania 15213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02457260, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 17, 2018 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02457260 live on ClinicalTrials.gov.

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