Ketone and Hawthorn Extract Supplementation in Congestive Heart Failure (NCT07166965) | Clinical Trial Compass
By InvitationNot Applicable
Ketone and Hawthorn Extract Supplementation in Congestive Heart Failure
United States45 participantsStarted 2025-11-15
Plain-language summary
The purpose of this research is to gain a better understanding of whether supplements can improve heart health. There are a number of study procedures and tests that will occur as a part of the research study. There are 3 groups or arms in the study: one group will receive a ketone supplement, one group will receive hawthorn and a third group will receive a placebo that does not contain ketones or hawthorn. The purpose of the study is to learn whether these supplements improve heart heath in patients who have congestive heart failure.
Participants will not know which supplement is received. The study doctor will know. This is called a single blind study. The supplements will provided along with instructions and educational materials. The duration of taking the supplements is approximately 8 weeks and full participation in the study is approximately 3 months. Participants with congestive heart failure will be enrolled through Jefferson Health in Philadelphia, Pennsylvania.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Current use of supplemental oxygen, aside from nocturnal O2 for the treatment of obstructive sleep apnea
. The use of steroids/antibiotics within the past 6 months for an acute exacerbation of obstructive pulmonary disease
. 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)
. Proximal 6-minute walk test during which the subject experienced desaturation (\<94%) without subsequent normal study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure and Compare Changes in Myocardial Function: exercise capacity
Timeframe: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
2
Measure and Compare Changes in Myocardial Function: Structure and heart function
Timeframe: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.