Ketone and Hawthorn Extract Supplementation in Congestive Heart Failure

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07166965
Status
Enrolling By Invitation

Conditions

  • Congestive Heart Failure(CHF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hawthorn supplement — DIETARY_SUPPLEMENT
    Hawthorn oral supplement
  • Ketones — DIETARY_SUPPLEMENT
    ketone oral supplement
  • Placebo Control — OTHER
    Placebo Control, oral supplement

Study Details

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.

Key Dates

Start date
Nov 15, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Experimental: Ketone supplementation
    commercially available nutritional ketone monoester
  • Experimental: Hawthorn extract
    commercially available Hawthorn extract
  • Placebo Comparator: Placebo
    Placebo supplement

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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Thomas Jefferson University· Philadelphia, PA

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