MedTrace Logo

Oral Nitrite for Older Heart Failure Patients

NCT02457260 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-09-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

14 N Sodium Nitrite

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

Sponsors & Collaborators

  • Gladwin, Mark, MD

    lead INDIV

Principal Investigators

  • Daniel Forman, MD · University of Pittsburgh

  • Mark Gladwin, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-08
Primary Completion
2017-03-06
Completion
2017-03-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457260 on ClinicalTrials.gov