At a glance
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Inorganic Nitrite to Enhance Benefits From Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF)
In Brief
A Phase 2 clinical trial evaluating Placebo, Sodium Nitrite, and 2 other interventions for Heart Failure. Completed, enrolled 92 participants across 1 site.
Detailed Summary
Participants with heart failure with preserved ejection fraction will undergo 12 weeks of cardiac rehabilitation for exercise training (ET) and be randomized to either sodium nitrite or placebo through the training period. Study drug is administered 3 times daily with one of these doses being 30 minutes prior to onset of ET sessions throughout the12 week trial. The objective is to determine if the sodium nitrite improves the clinical responses and tolerability of ET.
Study Details
Timeline
Interventions
administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.