Actively Recruiting
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)
Led by Washington University School of Medicine · Updated on 2026-05-06
75
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to less than 80 years at consent
- Diagnosis of heart failure with reduced ejection fraction
- New York Heart Association (NYHA) Class II or III at screening
- Ejection fraction less than 45% measured by echocardiography at screening
- Stable medical therapy without major changes in key heart medications for 60 days before screening
- Ability and willingness to sign informed consent; legally authorized representatives not allowed
You will not qualify if you...
- Vulnerable populations including prisoners and children
- Use of pharmacologic or organic nitrate therapy within 3 months before screening
- Major orthopedic, psychiatric, neurological, or other conditions preventing exercise testing
- Estimated glomerular filtration rate under 45 mL/min/1.73m2 at screening
- Systolic blood pressure less than 90 or greater than 180 mmHg at screening
- Diastolic blood pressure less than 40 or greater than 100 mmHg at screening
- Previous adverse reaction to nitrate before screening
- Use of phosphodiesterase inhibitors within 3 months before screening and unwillingness to stop during trial
- Diagnosis of primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, or complex congenital heart disease before screening
- Active collagen vascular disease at screening
- Recent coronary interventions or bypass surgery within 3 months before screening
- Severe valvular heart disease at screening
- Severe liver disease with encephalopathy or variceal bleeding
- Terminal disease with expected survival less than 1 year at screening
- Enrollment in another therapeutic trial at screening
- Pregnant, breastfeeding, or postmenopausal women on estrogen replacement therapy at screening
- Women or men of childbearing potential must agree to use two effective birth control methods during the study
- Need for oxygen at rest or during exercise before screening
- Active angina or ischemia before or at screening
- Use of xanthine oxidase inhibitors at screening
- Use of proton pump inhibitors or antacids at screening if unable to stop during the study; Tums must be stopped 5 days before key visits
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
D
Dawson A Haley, B.S.
CONTACT
S
Susan B Racette, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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