NCT07166965

Ketone and Hawthorn Extract Supplementation in Congestive Heart Failure

A Pilot Study of Ketone and Hawthorn Extract Supplementation: Impact on Exercise Capacity, and Heart Function in Patients With Congestive Heart Failure

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hawthorn supplement	Hawthorn oral supplement
DIETARY_SUPPLEMENT	Ketones	ketone oral supplement
OTHER	Placebo Control	Placebo Control, oral supplement

Timeline

• Start date: 2025-11-15
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2025-09-11
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States