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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
45
Hawthorn oral supplement
ketone oral supplement
Placebo Control, oral supplement
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
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.
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 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.
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 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.
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
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.
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.
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