Effects of Keto Diet in People with HFpEF
Trial Objectives
The keto diet has helped many people lose weight and improve their overall health. Researchers are investigating if it can also benefit people with a specific type of heart failure.
More than half of people with heart failure have a condition called Heart Failure with preserved Ejection Fraction (HFpEF). This condition reduces the amount of oxygen-rich blood that the heart can deliver to tissues and organs, but people with this disease can live longer than those with other types of heart failure with proper treatment and lifestyle adjustment.
Researchers in this clinical trial are comparing the use of a low-carb, high-fat diet ketogenic diet and a diet with balanced nutrient levels in participants with HFpEF. Volunteers will be randomly selected to follow either the keto diet or the balanced diet for the duration of the study. The purpose of the study is to determine how well participants adhere to the diets, the benefits they show for people with this health condition, and at what rate people drop off of the dietary recommendations. A secondary study will further evaluate the effects of dietary supplementation with oral ketone ester on heart biomarkers and exercise physiology in participants both with HFpEF and healthy participants.
Volunteers will be administered an oral ketone supplement, and will undergo right heart catheterization, CPET, and cardiac PET scans. Total study participation is 2-3 weeks.
Who Can Participate
Primary Study: Participants must have a diagnosis of Heart Failure with preserved Ejection Fraction (HFpEF) or Pulmonary Hypertension and Heart Failure with preserved Ejection Fraction (PH-HFpEF) and will be screened for other exclusion criteria.
Secondary study: 2 participants will be selected with a diagnosis of metabolic syndrome (metS) and HFpEF, 2 participants with a diagnosis of metS and PH-HFpEF, and two healthy participants who have neither metS nor HFpEF.
Age: 21-79 Gender: Any
Estimated Time Commitment
12-week post-study testing is complete. There will be an option to enroll in a 12-week extension arm (for a total of 24 weeks). Primary study commitment will involve a total of 9 visits
Payment & Reimbursement
Payment: Provided
Travel Reimbursement: Not Available
Trial Location
National Jewish Main Campus, Denver, CO
Trial Sponsors
Keto Research Fund
Principal Investigators
Marjorie Patricia George, MD
Co-Investigators
Darlene Kim, MD, FACC