At a glance
ClinicalIndex Comparison Record- ✓Age 18-79 years at consent
- ✓Diagnosis of heart failure with reduced ejection fraction
- ✓NYHA Class II-III at Visit 1
- ✓Ejection fraction less than 45% by transthoracic echocardiography
- ✕Vulnerable populations, prisoners, children
- ✕Pharmacologic organic nitrate therapy within 3 months prior to Visit 1
- ✕Major orthopedic, psychiatric, neurological, or other conditions hindering ability to complete exercise tests
- ✕eGFR less than 45 mL/min/1.73m2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF) -a Phase II Clinical Trial
In Brief
A Phase 2 clinical trial evaluating KNO3 and Placebo for Heart Failure. Currently recruiting, targeting 75 participants across 1 site.
Detailed Summary
The goals of this project are to determine the effectiveness of acute (2 hours after a single dose) and chronic (after 6 weeks of once-a-day dosing) KNO3 treatment (10mmol) vs. placebo on quadriceps muscle power and on aerobic exercise performance (V̇O2peak) in patients with HFrEF (left ventricular ejection fraction \<45%). The investigators hypothesize that both acute and chronic dosing of 10mmol of KNO3 will improve exercise performance in HFrEF. To test this hypothesis, the investors will perform a randomized, double-blind, placebo-controlled, parallel-arm design study.
Study Details
Timeline
Interventions
10 mmol of KNO3 via a single gel capsule to be consumed orally once per day for 6 weeks.
10 mmol of placebo via a single gel capsule to be consumed orally once per day for 6 weeks.