NCT02713126

Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training)

Inorganic Nitrite to Enhance Benefits From Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Barry Borlaug · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Placebo	administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
DRUG	Sodium Nitrite	administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
DEVICE	Accelerometer	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.
OTHER	Cardiac Exercise Training	Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-04-12
• Completion: 2022-04-12
• First posted: 2016-03-18
• Last updated: 2023-04-26
• Results posted: 2023-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study