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NCT07166965

Ketone and Hawthorn Extract Supplementation in Congestive Heart Failure

Enrolling by Invitation
NAAges 18+Interventional
Thomas Jefferson University
~45 participants
Updated 2025-11-18 on ClinicalTrials.gov
What's tested:Hawthorn supplementKetonesPlacebo Control

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure and Compare Changes in Myocardial Function: exercise capacity
Measured over From baseline enrollment evaluations with functional measures to the end of supplementation at 8 weeks and evaluations afterwards at weeks 10 to 12.
+1 more outcome measured

Conditions

Congestive Heart Failure(CHF)

Explore related trials

Congestive Heart Failure

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Andrew B Newberg, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University, Marcus Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).
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

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:
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.

What this trial measures

  • Measure and Compare Changes in Myocardial Function: exercise capacityFrom 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 functionFrom 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.