drugset / Trial / NCT02713126
Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training)
Phase 2
Completed
92 enrolled
Barry Borlaug
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2016-09
- Primary completion
- 2022-04-12
- Completion
- 2022-04-12
Publications
- Borlaug BA, Koepp KE, Reddy YNV, Obokata M, Sorimachi H, Freund M, Haberman D, Sweere K, Weber KL, Overholt EA, Safe BA, Omote K, Omar M, Popovic D, Acker NG, Gladwin MT, Olson TP, Carter RE. Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction: The INABLE-Training Trial. Mayo Clin Proc. 2024 Feb;99(2):206-217. doi: 10.1016/j.mayocp.2023.08.031. Epub 2023 Dec 21.
- Alogna A, Koepp KE, Sabbah M, Espindola Netto JM, Jensen MD, Kirkland JL, Lam CSP, Obokata M, Petrie MC, Ridker PM, Sorimachi H, Tchkonia T, Voors A, Redfield MM, Borlaug BA. Interleukin-6 in Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2023 Nov;11(11):1549-1561. doi: 10.1016/j.jchf.2023.06.031. Epub 2023 Aug 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sodium Nitrite | Small molecule | 40 mg | Oral |