RecruitingNot applicable

Ketogenic Diet vs Mixed Diet in Patients With Heart Failure

A Prospective Randomized Unblinded Study of Ketogenetic Versus Mixed Diet on Exercise Tolerance in Subjects With the Metabolic Phenotype of Heart Failure With Preserved Ejection Fraction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Physical exams, X-rays, MRI scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "An in-person physical exam by one of the physician investigators. 2."
  • "A Dual-energy X-ray absorptiometry (DXA) test, which is a test to measure your body composition."
  • "There is a small amount of radiation used in DXA, which is extremely low (by comparison, a standard chest x-ray is 125 times more radiation than a DXA scan). 3."
  • "Two cardiac magnetic resonance imaging (MRI) scans."
  • "One consisting of non-contrast resting scans including elastography (MR safe drum-like device will generate mechanical waves on specific organs to test the stiffness of these organs) and another consisting of a contrast-enhanced MRI scan of the heart (The one with contrast will only be performed twice for the study, once at the baseline and once end of the study). 4."
  • "Blood draws may cause discomfort at the skin puncture site and a small bruise may develop that may persist for several weeks."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusions: 1. Age ≥ 18 years old and ≤ 80 years old \& willingness to be randomized to either diet. 2. NYHA class I - III for at least 3 months. 3. Ejection fraction ≥40% by biplane 2D, or 3D echo, or CMR 4. 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. 5. 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). 6. Dose of oral diuretics changes allowed but must be stable for 1 week prior to randomization. 7. 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. 8. Ability to participate in exercise treadmill testing. 9. Ability to sign written consent. Exclusions: 1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the study. 2. Known allergy or sensitivity to gadolinium-based contrast agents. 3. Implanted pacemaker, cardioverter defibrillator, Cardiac resynchronization therapy, left ventricular assist device. 4. Other metallic implants/aneurysm clips that are contraindicated in MRI. 5. Claustrophobia 6. History of severe kidney disease of estimated glomerular filtration rate (eGFR) \<30 ml/kg/1.73m2. 7. Type I diabetes. 8. History of diabetic ketoacidosis. 9. Prior diagnosis of oxygen dependent pulmonary disease. 10. Body Mass Index (BMI) \< 25. 11. Recent acute myocardial infarction or acute coronary syndrome (30 days). 12. 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. 13. Left ventricular ejection fraction \< 50%. 14. Uncontrolled systemic systolic blood pressure (SBP)/diastolic blood pressure (DBP) hypertension (SBP \>180 or DBP \>110 mmHg). 15. Severe stenotic or regurgitant valvular heart disease, expected to lead to surgery during the study period. 16. Persistent atrial fibrillation. 17. History of uncontrolled or untreated ventricular arrhythmias. 18. Cardiovascular diseases or treatments that increase the unpredictability of or change the subject's clinical course, independent of heart failure. 19. Heart transplant or listing for heart transplant. 20. 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. 21. 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. 22. Hemoglobin of \<9 g/dL at screening. 23. 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. 24. 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. 25. Gastrointestinal surgery or gastrointestinal disorder that might interfere with diet. Prior bariatric surgery allowed if weight-stable for past 3 months. 26. 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). 27. Presence of any disease other than heart failure that results in a life expectancy of \<1 year (in the opinion of the investigator). 28. History or recurrent severe hypokalemia, potassium \< 3.0 mg/dL. 29. Current enrollment or completion within 30 days of an investigational device or drug study. 30. 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. 31. Any other clinical condition that might jeopardize subject safety during participation in this study or prevent the subject from adhering to the study protocol. 32. Unable or unwilling to follow guidelines of assigned diet group, including inability to purchase food. 33. Unable to participate in the comprehensive diet program, including biometric data acquisition and data entry. 34. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required. 35. 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. 36. Refusal to consent.

Study sites (1)

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