The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)
Eligible age
19–79 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ 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 converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB or aldosterone antagonists) or ARNI (ARB + sacubitril)
- ✓ Ability and willingness to sign an IRB approved written informed consent form; legally authorized representatives are not allowed in this study
You may not qualify if…
- ✕ To participate in this study, a patient must not meet any of the criteria listed below:
- ✕ Vulnerable populations as defined by the U.S. Department of Health and Human Services; prisoners and children will be excluded from this study
- ✕ Pharmacologic, organic nitrate therapy within 3 months prior to Visit 1
- ✕ Major orthopedic, psychiatric, neurological, or other conditions that would hinder the ability to complete the exercise tests at the time of Visit 1
- ✕ Estimated glomerular filtration rate less than 45 mL/min/1.73m2 on screening clinical laboratories measured at Visit 1
- ✕ Systolic blood pressure less than 90mmHg or greater than 180mmHg at Visit 1
- ✕ Diastolic blood pressure less than 40mmHg or greater than 100mmHg at Visit 1
- ✕ Previous adverse reaction to nitrate prior to Visit 1
Where it's recruiting
St Louis
Source: ClinicalTrials.gov · NCT05562167 · last updated 2026-05-06