12 Week Study of Inhaled Nitrite for Improving Cardiac Function

Participants with heart failure with preserved ejection fraction will undergo 12 weeks of cardiac rehabilitation for exercise training (ET) and be randomized to either nebulized sodium nitrite inhalation solution or placebo inhalation solution (normal saline) through the training period. Study drug is administered 3 times daily during daytime hours with one of these doses being immediately prior to onset of ET sessions throughout the 12 week trial. The objective is to determine if the inhaled sodium nitrite improves clinical responses to ET.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Inorganic Nitrite to Enhance Benefits From Exercise Training in Heart Failure With Preserved Ejection Fraction
Estimated Enrollment: 80
Study Start Date: April 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Arms:
- Placebo Comparator: Placebo
- Active Comparator: Sodium Nitrite