Congestive Heart Failure(CHF)NCT07166965
Ketone and Hawthorn Extract Supplementation in Congestive Heart Failure
A study testing Hawthorn supplement and Ketones in people with Congestive Heart Failure(CHF), run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure(CHF)
- What is being tested?
- Hawthorn supplement and Ketones
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study of Ketone and Hawthorn Extract Supplementation: Impact on Exercise Capacity, and Heart Function in Patients With Congestive Heart Failure
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.
Read the detailed description
This is a Randomized, placebo-controlled single blind pilot study; the duration of the study enrollment is 24 months. It will be conducted at Thomas Jefferson University, Departments of Integrative Medicine, and Nutritional Sciences; Department of Cardiology. Locations: Marcus Institute Centers of Integrative Health at Villanova and Center City Philadelphia. The enrollment goal is 45: 15 in each study arm, ketone, hawthorn extract, or placebo. The investigators will increase each arm by three for a total of 54 to allow for attrition and early withdrawals. Participants will receive a commercially available Hawthorn extract or nutritional ketone monoester, or placebo.
The Investigators will enroll patients with a diagnosis of stable, ambulatory heart failure, classified by the New York Heart Association (NYHA) as functional Class II or III by their cardiologist and/or by the Principal Investigator.
- Conditions
- Congestive Heart Failure(CHF)
- Being tested
- Hawthorn supplement, Ketones, Placebo Control
- Keywords
- Heart Failure classified as NYHA Class II or III
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hawthorn supplementDietary supplement
Hawthorn oral supplement
KetonesDietary supplement
ketone oral supplement
Placebo ControlOther
Placebo Control, oral supplement
| Study group | Role | What they receive |
|---|---|---|
| Ketone supplementation | Experimental | commercially available nutritional ketone monoester Receives: Dietary Supplement: Ketones |
| Hawthorn extract | Experimental | commercially available Hawthorn extract Receives: Dietary Supplement: Hawthorn supplement |
| Placebo | Placebo comparator | Placebo supplement Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure and Compare Changes in Myocardial Function: exercise capacity
Compare outcomes of functional measures - exercise capacity as measured by oxygen consumption at peak and anaerobic threshold (VO2peak and VO2at) and exercise duration.
Exercise capacity is measured objectively through laboratory Cardiopulmonary Exercise Tests (CPETs) combined metrics which use equipment to monitor heart rate, breathing, and oxygen consumption; with VO2 peak setting the ceiling for endurance and VO2AT.
Exercise capacity, measured by oxygen consumption (VO2), to measure the body's ability to take in and use oxygen during exercise, with VO2 peak representing the maximum capacity reached and VO2 at the anaerobic threshold (VO2AT) at rest and during peak exercise following approximately 2 months of receiving the respective supplementation or placebo.
Measured: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Measure and Compare Changes in Myocardial Function: Structure and heart function
Compare outcomes of functional measures as measured by changes in myocardial function (evaluate the structure and function of the heart and blood vessels) at rest as measured by Cardiac Magnetic Resonance Imaging (cMRI) indexes of Left ventricular ejection fraction (LVEF) and Right Ventricular Ejection Fraction (RVEF) and myocardial performance at peak exercise (cardiac output [CO] and LVEF) as measured by echocardiogram at rest and during peak exercise following approximately 2 months of receiving the respective supplementation or placebo.
Measured: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Secondary outcomes (2)
Measure and Compare Changes Associated with Supplementation using FDG PET and Cardiac MRI
Compare changes associated with the respective nutraceutical supplementation in cardiac glucose uptake as measured by Fluoro deoxy glucose Positron Emission Tomography (FDG PET) and cardiac function as measured by cardiac MRI.
Measured: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Measure and Compare Changes Associated with Cardiac Metabolism using FDG PET and Cardiac MRI
Compare changes associated with the respective nutraceutical supplementation in cardiac glucose uptake as measured by Fluoro deoxy glucose Positron Emission Tomography (FDG PET) and cardiac function as measured by cardiac MRI.
Measured: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start15 Nov 2025 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure(CHF)Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomization and Intervention At the conclusion of Visit 1, subjects will be randomized to either Group A, B, or C. Group A will be given an over-the-counter Hawthorn extract 500mg capsules to be taken two capsules twice per day. Group B will be given the ketone drink (Ketone-IQ) to take 4 oz (33g) three times per day. Group C will be given 4 oz of a placebo drink and instructed to take it three times per day. All subjects will be instructed to take their intervention for 2 months between the two evaluation visits. The randomization and use of supplements will be conducted after all the baseline evaluations are completed: PET MRI, echocardiogram, VO2 MAX. The study doctor will decide based on these tests and procedures at this to whether the potential participants would be able to safely participate in the study. The clinical determination of the level of heart disease will be evaluated by the study doctors.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew B Newberg, MD, Principal investigator, Thomas Jefferson University, Marcus Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166965
- Sponsor's protocol ID
- Oncore45335, iRISID-2025-0253
- Status last verified
- Nov 2025
- First submitted
- 30 Jul 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ketone and Hawthorn Extract Supplementation: Impact on Exercise Capacity, and Heart Function in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT07166965
- Acronym / sponsor ID
- Oncore45335, iRISID-2025-0253
- Conditions
- Congestive Heart Failure(CHF)
- Keywords
- Heart Failure classified as NYHA Class II or III
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Randomized, placebo-controlled single blind pilot study; the duration of the study enrollment is 24 months. It will be conducted at Thomas Jefferson University, Departments of Integrative Medicine, and Nutritional Sciences; Department of Cardiology. Locations: Marcus Institute Centers of Integrative Health at Villanova and Center City Philadelphia. The enrollment goal is 45: 15 in each study arm, ketone, hawthorn extract, or placebo. The investigators will increase each arm by three for a total of 54 to allow for attrition and early withdrawals. Participants will receive a commercially available Hawthorn extract or nutritional ketone monoester, or placebo.
The Investigators will enroll patients with a diagnosis of stable, ambulatory heart failure, classified by the New York Heart Association (NYHA) as functional Class II or III by their cardiologist and/or by the Principal Investigator.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomization and Intervention At the conclusion of Visit 1, subjects will be randomized to either Group A, B, or C. Group A will be given an over-the-counter Hawthorn extract 500mg capsules to be taken two capsules twice per day. Group B will be given the ketone drink (Ketone-IQ) to take 4 oz (33g) three times per day. Group C will be given 4 oz of a placebo drink and instructed to take it three times per day. All subjects will be instructed to take their intervention for 2 months between the two evaluation visits. The randomization and use of supplements will be conducted after all the baseline evaluations are completed: PET MRI, echocardiogram, VO2 MAX. The study doctor will decide based on these tests and procedures at this to whether the potential participants would be able to safely participate in the study. The clinical determination of the level of heart disease will be evaluated by the study doctors.
| Arm | Type | Receives |
|---|---|---|
| Ketone supplementation | Experimental | Dietary Supplement: Ketonescommercially available nutritional ketone monoester |
| Hawthorn extract | Experimental | Dietary Supplement: Hawthorn supplementcommercially available Hawthorn extract |
| Placebo | Placebo comparator | Other: Placebo ControlPlacebo supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hawthorn supplementHawthorn oral supplement | Dietary supplement | Hawthorn extract |
| Ketonesketone oral supplement | Dietary supplement | Ketone supplementation |
| Placebo ControlPlacebo Control, oral supplement | Other | Placebo |
Primary outcome
Measure and Compare Changes in Myocardial Function: exercise capacity
Time frame: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Compare outcomes of functional measures - exercise capacity as measured by oxygen consumption at peak and anaerobic threshold (VO2peak and VO2at) and exercise duration. Exercise capacity is measured objectively through laboratory Cardiopulmonary Exercise Tests (CPETs) combined metrics which use equipment to monitor heart rate, breathing, and oxygen consumption; with VO2 peak setting the ceiling for endurance and VO2AT. Exercise capacity, measured by oxygen consumption (VO2), to measure the body's ability to take in and use oxygen during exercise, with VO2 peak representing the maximum capacity reached and VO2 at the anaerobic threshold (VO2AT) at rest and during peak exercise following approximately 2 months of receiving the respective supplementation or placebo.
Measure and Compare Changes in Myocardial Function: Structure and heart function
Time frame: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Compare outcomes of functional measures as measured by changes in myocardial function (evaluate the structure and function of the heart and blood vessels) at rest as measured by Cardiac Magnetic Resonance Imaging (cMRI) indexes of Left ventricular ejection fraction (LVEF) and Right Ventricular Ejection Fraction (RVEF) and myocardial performance at peak exercise (cardiac output [CO] and LVEF) as measured by echocardiogram at rest and during peak exercise following approximately 2 months of receiving the respective supplementation or placebo.
2 secondary outcomes
Measure and Compare Changes Associated with Supplementation using FDG PET and Cardiac MRI
Time frame: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Measure and Compare Changes Associated with Cardiac Metabolism using FDG PET and Cardiac MRI
Time frame: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew B Newberg, MD principal investigator
Thomas Jefferson University, Marcus Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hawthorn supplement and Ketones in people with Congestive Heart Failure(CHF), run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and Compare Changes in Myocardial Function: exercise capacity (time frame: From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.