Actively Recruiting
Ketogenic Diet vs Mixed Diet in Patients With Heart Failure
Led by Ohio State University · Updated on 2025-04-03
90
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketogenic Diet vs Mixed Diet in Patients With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years and willingness to be randomized to either diet
- New York Heart Association (NYHA) class I to III symptoms for at least 3 months
- Left ventricular ejection fraction of 40% or higher by echocardiogram or cardiac MRI
- Evidence of abnormal or indeterminate diastolic function or specific right heart catheterization measurements
- Stable medical therapy with no new cardiac or diabetic medications within 3 months and stable doses for at least 1 month
- Oral diuretic doses stable for 1 week prior to randomization
- Body Mass Index (BMI) of 25 or greater, or diagnosis of Type 2 diabetes, prediabetes, or metabolic syndrome
- Ability to participate in exercise treadmill testing
- Ability to provide written informed consent
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Allergy or sensitivity to gadolinium contrast agents
- Implanted pacemaker, defibrillator, cardiac resynchronization device, or left ventricular assist device
- Metallic implants or aneurysm clips that prevent MRI
- Claustrophobia
- Severe kidney disease with eGFR below 30 ml/kg/1.73m2
- Type I diabetes
- History of diabetic ketoacidosis
- Oxygen-dependent pulmonary disease
- Body Mass Index (BMI) below 25
- Recent heart attack or acute coronary syndrome within 30 days
- Recent or planned cardiac revascularization within 30 days
- Left ventricular ejection fraction below 50%
- Uncontrolled high blood pressure (SBP >180 or DBP >110 mmHg)
- Severe valvular heart disease expected to require surgery
- Persistent atrial fibrillation
- Uncontrolled or untreated ventricular arrhythmias
- Other cardiovascular diseases or treatments affecting clinical course
- Heart transplant or listed for transplant
- Specific cardiomyopathies or pericardial constriction
- Acute decompensated heart failure within 1 week prior to screening
- Hemoglobin below 9 g/dL at screening
- Major surgery within 90 days before or planned within 90 days after screening
- Acute or chronic liver disease with elevated liver enzymes
- Gastrointestinal surgery or disorders interfering with diet (prior bariatric surgery allowed if weight stable 3 months)
- Active or recent malignancy within 2 years (except certain low-risk cancers)
- Diseases limiting life expectancy to less than 1 year
- History of severe hypokalemia or potassium below 3.0 mg/dL
- Participation in another investigational study within 30 days
- Chronic alcohol or drug abuse or conditions preventing study adherence
- Unable or unwilling to follow diet guidelines or obtain food
- Inability to participate in diet program including data entry
- Current low-carb diet without 30-day washout
- Weight instability over past 3 months (±5%) without 1 month washout
- Refusal to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Ross Heart Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
D
Debbie Scandling, BS
CONTACT
A
Alyssa Marie Castillo, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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