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Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction

NCT02262078 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-08-29

Study results available
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Summary

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of nebulized inhaled nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.

Conditions

Interventions

DRUG

Sodium Nitrite Inhalation Solution

90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.

OTHER

Placebo

Normal saline will be administered (by inhalation) to participants prior to exercise.

Sponsors & Collaborators

  • Aires Pharmaceuticals, Inc.

    collaborator INDUSTRY

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

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Barry Borlaug, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT02262078 on ClinicalTrials.gov