RecruitingPhase 2NCT05562167

The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)

The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF) -a Phase II Clinical Trial


Sponsor

Washington University School of Medicine

Enrollment

75 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether inorganic nitrate supplements (found naturally in beets and leafy greens) can improve exercise capacity in people with heart failure with reduced ejection fraction — a condition where the heart muscle is weakened and pumps less blood than it should. Participants will undergo exercise testing to measure improvement. **You may be eligible if...** - You have heart failure with a reduced pumping function (ejection fraction below 45%) - Your heart failure is classified as moderate (NYHA Class II or III) - Your heart medications have been stable for at least 60 days **You may NOT be eligible if...** - You are a prisoner, a child, or in another vulnerable category - You took organic nitrate therapy (like nitroglycerin) in the past 3 months - You have a major orthopedic, psychiatric, or neurological condition that prevents exercise testing - Your kidney filtration rate is below 45 mL/min - Your blood pressure is too low or too high at screening - You use medications for erectile dysfunction (phosphodiesterase inhibitors) and are unwilling to stop - Your ejection fraction is 45% or higher - You have certain heart conditions (hypertrophic cardiomyopathy, amyloid, active myocarditis, complex congenital heart disease) - You have severe liver disease or another terminal illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05562167


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