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Could a simple salt boost heart failure Patients' exercise ability?

NCT ID NCT05562167

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a daily capsule of potassium nitrate (KNO3) can improve leg muscle power and overall exercise capacity in people with heart failure. 75 adults with reduced heart function will take either KNO3 or a placebo for 6 weeks. Researchers will measure changes in treadmill exercise performance and muscle strength.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
potassium nitrate (KNO3)
What this could lead to
If it works, this could point toward a simple, daily supplement to help people with heart failure exercise more easily and feel better.
What could go wrong
This is an early phase 2 trial with only 75 people, so results may not apply to everyone. The supplement might not improve exercise or could cause side effects like stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Exclusion Criteria 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 * Treatment with phosphodiesterase inhibitors within the last 3 months prior to Visit 1; Patient must also be willing to not take them for the duration of the trial * Diagnosis of primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloid), active myocarditis, or complex congenital heart disease prior to Visit 1 * Active collagen vascular disease at time of Visit 1 * Percutaneous coronary intervention, new bi-ventricular pacing, or coronary artery bypass grafting within the 3 months prior to Visit 1 * Valvular heart disease with severe regurgitation or stenosis of any valve, as demonstrated on the echocardiogram at Visit 1 * Known severe liver disease as evidenced by encephalopathy or variceal bleeding; * Terminal disease (other than heart failure) with expected survival less than 1 y at time of Visit 1 * Enrollment in another therapeutic trial at time of Visit 1 * Pregnant and breastfeeding women or postmenopausal women taking exogenous estrogen replacement therapy at time of Visit 1 * To meet this criterion, patients must have a negative urine pregnancy test and provide verbal confirmation that they are not breastfeeding at time of Visit 1. * Note, post-menopausal is defined as last menstrual period occurring greater than or equal to 12 months prior to Visit 1 or confirmation of prior bilateral oophorectomy at least 6 months prior to first dose of study drug. * Women of childbearing potential or men with childbearing potential partners must agree that the participant and/or their partner will use at least two of the following highly effective method of birth control from study entry until 48 hours after completing study therapy, if not abstaining from sexual activity: * Barrier method contraception (e.g., male or female condoms with or without a spermicidal agent, diaphragm, or cervical cap with spermicide) * Stable dose of injectable, depot, oral, implanted, intravaginal, or transdermal hormonal contraception for at least 30 days before sexual activity * Intrauterine device (IUD) with or without hormones * Surgical sterilization * For women, this includes hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal ligation, bilateral salpingectomy, completed at least 6 months before first dose of study drug. * For men, this includes vasectomy. * Patients requiring exogenous oxygen at rest or during exercise prior to Visit 1 * Patients with active angina at time of Visit 1 or ischemia due to epicardial coronary disease prior to or at time of Visit 1 * Patients taking xanthine oxidase inhibitors at time of Visit 1 * Individuals taking proton pump inhibitors and/or antacids at time of Visit 1, if unable to stop these medications for the duration of the study. * Note, while patients will be asked to refrain from taking these medications for the duration of the study, they may take tums. However, patients must discontinue Tums for 5 days prior to study visits 2, 3, and 4.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.