Official Title

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

Purpose

The purpose of this study is to compare the effects of a well-formulated ketogenic diet with a low-fat diet on exercise tolerance in patients with heart failure and diabetes or pre-diabetes or metabolic syndrome.

 

Could this study be right for you?

• 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 ≥50% by biplane 2D, or 3D echo, or CMR
• Echo findings of abnormal or indeterminant diastolic function or 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 and ≤ 50 or Type 2 Diabetes Mellitus or prediabetes (fasting glucose of 100 - 125 mg/dL or 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 devices.
• Other metallic implants/aneurysm clips that are contraindicated in MRI.           
• Claustrophobia
• History of severe kidney disease of eGFR<30 ml/kg/1.73m2.

 

Exclusion Criteria varies, please contact Study Coordinator. 

Age Range

18 - 80 years