Status:
RECRUITING
Ketogenic Diet vs Mixed Diet in Patients With Heart Failure
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is being done to evaluate the effects of a low carbohydrate ketogenic diet (KD) versus a low-fat diet (MD) on exercise tolerance in participants with heart failure with normal pumping funct...
Detailed Description
Participants will be randomized to either a ketogenic diet (KD), or a low-fat diet (MD). Participants will eat the specified diet for a period of 6-months and be supported by dietary coaching. All fo...
Eligibility Criteria
Inclusion
- Inclusions:
- Age ≥ 18 years old and ≤ 80 years old \& willingness to be randomized to either diet.
- NYHA class I - III for at least 3 months.
- Ejection fraction ≥40% by biplane 2D, or 3D echo, or CMR
- Echo findings of abnormal or indeterminant diastolic function or right heart catheterization (RHC) data: At rest: mean pulmonary capillary wedge pressure (PCWP) \> 15 mmHg. pulmonary vascular resistance (PVR) \< 3 Wood Units.
- Stable medical therapy for at least 3 months as determined by the treating physician (no new cardiac or diabetic medications within 3 months of enrollment or during enrollment and dosage should be stable for 1 month prior to enrollment).
- Dose of oral diuretics changes allowed but must be stable for 1 week prior to randomization.
- Body Mass Index (BMI) ≥ 25 or Type 2 Diabetes Mellitus or prediabetes (fasting glucose of 100 - 125 mg/dL or glycated hemoglobin (A1C) 5.7-6.4% or metabolic syndrome.
- Ability to participate in exercise treadmill testing.
- Ability to sign written consent.
- Exclusions:
- Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the study.
- Known allergy or sensitivity to gadolinium-based contrast agents.
- Implanted pacemaker, cardioverter defibrillator, Cardiac resynchronization therapy, left ventricular assist device.
- Other metallic implants/aneurysm clips that are contraindicated in MRI.
- Claustrophobia
- History of severe kidney disease of estimated glomerular filtration rate (eGFR) \<30 ml/kg/1.73m2.
- Type I diabetes.
- History of diabetic ketoacidosis.
- Prior diagnosis of oxygen dependent pulmonary disease.
- Body Mass Index (BMI) \< 25.
- Recent acute myocardial infarction or acute coronary syndrome (30 days).
- Or recent (within 30 days) or planned (within 30 days) cardiac revascularization History of left main disease, severe triple vessel disease, coronary artery bypass graft surgery.
- Left ventricular ejection fraction \< 50%.
- Uncontrolled systemic systolic blood pressure (SBP)/diastolic blood pressure (DBP) hypertension (SBP \>180 or DBP \>110 mmHg).
- Severe stenotic or regurgitant valvular heart disease, expected to lead to surgery during the study period.
- Persistent atrial fibrillation.
- History of uncontrolled or untreated ventricular arrhythmias.
- Cardiovascular diseases or treatments that increase the unpredictability of or change the subject's clinical course, independent of heart failure.
- Heart transplant or listing for heart transplant.
- Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction.
- Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents or mechanical support within 1 week of screening and during the screening period prior to randomization.
- Hemoglobin of \<9 g/dL at screening.
- Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening.
- Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening.
- Gastrointestinal surgery or gastrointestinal disorder that might interfere with diet. Prior bariatric surgery allowed if weight-stable for past 3 months.
- Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or low-risk prostate cancer (subjects with pre-treatment prostate-specific antigen levels of \<10 ng/mL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a).
- Presence of any disease other than heart failure that results in a life expectancy of \<1 year (in the opinion of the investigator).
- History or recurrent severe hypokalemia, potassium \< 3.0 mg/dL.
- Current enrollment or completion within 30 days of an investigational device or drug study.
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, will make the subject unlikely to fulfill the study requirements or complete the trial.
- Any other clinical condition that might jeopardize subject safety during participation in this study or prevent the subject from adhering to the study protocol.
- Unable or unwilling to follow guidelines of assigned diet group, including inability to purchase food.
- Unable to participate in the comprehensive diet program, including biometric data acquisition and data entry.
- The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.
- Patient has to have stable weight over the past 3 months (± 5% total body weight). If no weight was recorded in the past 3 months, will have 1 month lead in time for wash out.
- Refusal to consent.
Exclusion
Key Trial Info
Start Date :
May 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06081543
Start Date
May 19 2023
End Date
August 31 2026
Last Update
April 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ross Heart Hospital
Columbus, Ohio, United States, 43210