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Compares treatment options for Heart Failure With Preserved Ejection Fraction
Official title Ketogenic Diet vs Mixed Diet in Patients With Heart Failure
ClinicalTrials.gov ID: NCT06081543
What this study is testing
- What it's testing
- 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 function and diabetes or pre-diabetes, or metabolic syndrome, or obesity.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Inclusions:
- Age ≥ 18 years old and ≤ 80 years old \& willingness to be assigned by chance 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...
See the full eligibility criteria
- Inclusions:
- Age ≥ 18 years old and ≤ 80 years old \& willingness to be assigned by chance 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...
- 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...
- 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)...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Compensation & support
Some study costs may be covered. A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.