Ketones in Heart Failure With Reduced Ejection Fraction

Launched by DUKE UNIVERSITY · Dec 26, 2023

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Eligibility criteria

• Inclusion Criteria:
• • 1. Stable cardiovascular medical therapy for 2 weeks
• • 2. Participants will be required to have heart failure with reduced ejection fraction (left ventricular EF \</= 45%) and New York Heart Association (NYHA) class II or III symptoms. In cases of ambiguity of functional status, reduced peak VO2 (\<85% predicted VO2) at the baseline visit can be used to confirm reduced exercise tolerance.
• Exclusion Criteria:
• • 1. Intentional ketogenic diet in the last week
• • 2. Cirrhosis or significant alcohol consumption
• • 3. Contraindications to stress testing, conditions that limit exercise, and other clinically-significant causes of exertional limitation (claudication with peripheral artery disease, atrial fibrillation and heart rate \>110 at rest, systolic blood pressure\>180 mmHg or diastolic blood pressure\>110 mmHg, infiltrative/hypertrophic cardiomyopathy, clinically significant pericardial disease, joint or neuromuscular disease that precludes exercise, acute coronary syndrome within the last 2 months, estimated glomerular filtration rate\<20 mL/min/1.73 m2, and hemoglobin \< 9 mg/dL).
• • 4. Clinically significant lung disease: supplemental oxygen (aside from obstructive sleep apnea), chronic obstructive pulmonary disease requiring home oxygen or exacerbation within the last 2 months requiring steroids or antibiotics, severe obstructive lung disease (Gold stage 3).
• • 5. \>/= Moderate aortic stenosis, \>mild mitral stenosis, \> moderate aortic or mitral regurgitation
• • 6. Type 1 diabetes mellitus
• • 7. Implant of cardiac resynchronization therapy, cardiac contractility modulation, or barostim device within the previous 3 months.
• • 8. Systolic blood pressure \<90 mmHg
• • 9. Pregnant women
• • 10. Angina due to epicardial coronary disease or known presence of clinically-significant, unrevascularized epicardial coronary disease, in the investigator's opinion.
• • 11. History of heart transplant, left ventricular assist device, or use of inotropic medication.
• • 12. Participation in another clinical study with an investigational product in the previous 4 weeks prior to enrollment.
• • 13. Conditions that may render the patient unable to complete the study