drugset / Trial / NCT02457260
Oral Nitrite for Older Heart Failure Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational new drug (IND) approved sodium nitrite (10 milligram \[mg\]) capsule, and its utility to upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP) pathway of skeletal muscle of younger heart failure (HF) patients. It now seems exceptionally logical and opportune to apply these insights to older HF patients and to delineate mechanisms of disease and aging that respond to nitrite therapy.
Timeline
- Start
- 2016-01-08
- Primary completion
- 2017-03-06
- Completion
- 2017-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Nitrite | Small molecule | 20 mg | Oral |
| Subject | Sodium Nitrite | Small molecule | 40 mg | Oral |