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Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction

NCT02918552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-22

Study results available
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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.

Conditions

Interventions

DRUG

sodium nitrite

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

DRUG

Control

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Gladwin, Mark, MD

    lead INDIV

Principal Investigators

  • Daniel E Forman, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2018-12-02
Completion
2018-12-31
FDA Drug
Yes

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 NCT02918552 on ClinicalTrials.gov