Heart failure patients test natural supplements for better stamina
NCT ID NCT07166965
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether taking ketone or hawthorn supplements for 8 weeks can improve exercise ability and heart function in people with congestive heart failure. About 45 adults with mild to moderate heart failure will be randomly assigned to receive one of the supplements or a placebo. Researchers will measure changes in oxygen use during exercise and heart structure using scans and stress tests.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Equal to or greater than 18 years of age * Diagnosis of heart failure and be classified as NYHA Class II or III either pre-enrollment or at the time of enrollment: Class II - Patients with cardiac disease resulting in slight limitation of physical activity who are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea (shortness of breath or difficulty breathing). Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea (shortness of breath or difficulty breathing). * Stable guideline directed medical therapy for at least 1 month prior to enrollment, including no changes in maintenance diuretic dosing * Taking appropriate guideline directed medical therapy as determined by the investigator, who is a heart failure specialist. Exclusion Criteria * Patients with Type I DM * No metal in the body that would prevent undergoing an MRI scan. This includes pacemakers, stents and non-titanium implants that would be contraindicated for an MRI. * Atrial fibrillation * Inability to exercise on a treadmill. * Moderate or greater valvular disease: a condition where the valves of the heart do not function properly. * Anemia with Hemoglobin \<10 g/dL. * Daily insulin use * Hypertrophic, infiltrative, or inflammatory cardiomyopathy (a group of heart muscle diseases where the heart muscle becomes abnormally thickened (hypertrophic), invaded by abnormal substances (infiltrative), or inflamed (inflammatory), which can lead to impaired heart function and potential complications like arrhythmias and heart failure. * Pericardial disease: a general term for conditions that affect the pericardium, the sac that surrounds the heart. Pericardial diseases include pericarditis, pericardial effusion, cardiac tamponade, and constrictive pericarditis.. * Current angina due to clinically significant obstructive epicardial coronary disease. a condition where the major coronary arteries on the surface of the heart (epicardial arteries) become significantly narrowed due to plaque buildup, restricting blood flow to the heart muscle, often causing chest pain and potentially leading to a heart attack. * Acute coronary syndrome (ACS) refers to a group of conditions where blood flow to the heart is suddenly reduced, causing chest pain or discomfort. * Coronary intervention within the past 2 months is a medical procedure used to treat ACS by opening a blocked coronary artery, typically done through a minimally invasive technique called percutaneous coronary intervention (PCI). * Primary pulmonary arteriopathy is also known as pulmonary arterial hypertension (PAH) or primary pulmonary hypertension (PPH), a rare disorder that causes high blood pressure in the pulmonary arteries. * Known clinically significant lung disease defined as: 1. Current use of supplemental oxygen, aside from nocturnal O2 for the treatment of obstructive sleep apnea 2. The use of steroids/antibiotics within the past 6 months for an acute exacerbation of obstructive pulmonary disease 3. Proximal pulmonary function test (PFT) indicating severe obstructive disease, defined as an FEV1\<50% predicted in the context of an FEV1/FVC ratio of \<0.70 ("Stage III COPD according to GOLD Criteria: significantly reduced lung function and often accompanied by noticeable symptoms like increased breathlessness, frequent exacerbations, and reduced exercise capacity). (note: only to be used if the subject had PFTs prior to screening) 4. Proximal 6-minute walk test during which the subject experienced desaturation (\<94%) without subsequent normal study. * Ischemia on stress testing without subsequent revascularization or left heart catheterization showing non-obstructive epicardial coronary disease. * Significant liver diseases impact on synthetic function or volume control. * Uncontrolled hypertension: BP \>180/110 at baseline. * Estimated glomerular filtration rate (eGFR) eGFR \<30 mL/min/173m2 indicating reduced kidney function * Creatinine level of Cr \>2.5 (2.5 mg/dL) is an indicator of stage 2 chronic kidney disease (CKD). * Current Alcohol dependence * Current substance use disorder. * Chronic narcotic use that cannot be interrupted * Pregnant or lactating females * Subject has a medical, mental or psychiatric disorder or physical condition that could reasonably be expected to interfere with the assessment of cardiac symptoms, or with any of the study assessments or study procedures including the PET-MRI imaging, VO2 Max, Echocardiogram ultrasound, blood samples that would put the study participant at great risk.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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