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

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

April 12, 2022

Study Completion Date

April 12, 2022

Conditions
Heart Failure
Interventions
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.

Trial Locations (1)

55905

Mayo Clinic, Rochester

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Barry Borlaug

OTHER

NCT02713126 - Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) | Biotech Hunter | Biotech Hunter