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Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF

NCT02742129 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-03-13

Study results available
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Summary

A randomized, double-blind, placebo-controlled crossover study to assess the effect of inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing. Approximately 100 participants will be enrolled in this 2\*2 crossover study.

Conditions

Interventions

DRUG

Nebulized Sodium Nitrite

Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.

DRUG

Placebo

Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Aires Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University of Vermont

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Adrian Hernandez

    lead OTHER

Principal Investigators

  • Kevin Hernandez, MD · Duke Clinical Research Institute

  • Eugene Braunwald, MD · Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-10
Primary Completion
2017-12-13
Completion
2017-12-27

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02742129 on ClinicalTrials.gov