The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF) -a Phase II Clinical Trial
Washington University School of Medicine
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.
Description
Visit 1 - Screening Visit 1 will be considered the screening visit. Participants will not be required to fast for this visit. This visit will be conducted over approximately 1.5 to 2 hours. The following procedures will be completed during this visit: 1. Informed consent, if not already obtained previously. 2. Health questionnaire 3. Review of medical history and concomitant medication usage 4. Review of any patient reported eligibility criteria (e.g., agreeance to using birth control, not using phosphodiesterase, inhibitors, etc.) 5. Labs a. As this is the only blood sample collected du…
Eligibility
- Age range
- 19–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria To participate in this study, a patient must meet all of the criteria listed below: * Males and females aged greater than or equal to 18y and less than 80y at time of consent * Diagnosis of heart failure with reduced ejection fraction * New York Heart Association (NYHA) Class II-III at Visit 1 * Ejection fraction less than 45%, as evaluated through transthoracic echocardiography at Visit 1 * Stable medical therapy, defined by no addition or removal (or change of more than 100 percent) of the following for 60 days prior to Visit 1: beta-adrenergic blockade and angiotensin c…
Interventions
- DrugKNO3
10 mmol of KNO3 via a single gel capsule to be consumed orally once per day for 6 weeks.
- DrugPlacebo
10 mmol of placebo via a single gel capsule to be consumed orally once per day for 6 weeks.
Location
- Washington University School of MedicineSt Louis, Missouri