Ketone and Hawthorn Extract Supplementation in Congestive Heart Failure

NCT07166965 | Enrolling By Invitation

• 1 other identifier: Oncore45335, iRISID-2025-0253
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congestive Heart Failure(CHF)

Keywords

Heart Failure classified as NYHA Class II or III

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.

Other Outcomes (2)

• Height in inches

  From baseline enrollment evaluations with functional measures

• Weight in pounds

  From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.

Study Arms (3)

Ketone supplementation

EXPERIMENTAL

commercially available nutritional ketone monoester

Dietary Supplement: Ketones

Hawthorn extract

EXPERIMENTAL

commercially available Hawthorn extract

Dietary Supplement: Hawthorn supplement

Placebo

PLACEBO COMPARATOR

Placebo supplement

Other: Placebo Control

Interventions

Hawthorn supplement DIETARY_SUPPLEMENT

Hawthorn oral supplement

Hawthorn extract

Ketones DIETARY_SUPPLEMENT

ketone oral supplement

Ketone supplementation

Placebo Control OTHER

Placebo Control, oral supplement

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Current use of supplemental oxygen, aside from nocturnal O2 for the treatment of obstructive sleep apnea

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Ketones

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

• Andrew B Newberg, MD

  Thomas Jefferson University, Marcus Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: September 11, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)