Ketones in Heart Failure With Reduced Ejection Fraction

Korábbi kezelés

• Implant of cardiac resynchronization therapy, cardiac contractility modulation, or barostim device within the previous 3 months.
• Participation in another clinical study with an investigational product in the previous 4 weeks prior to enrollment.

Más betegség

• 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).
• Type 1 diabetes mellitus
• Angina due to epicardial coronary disease or known presence of clinically-significant, unrevascularized epicardial coronary disease, in the investigator's opinion.
• History of heart transplant, left ventricular assist device, or use of inotropic medication.
• Conditions that may render the patient unable to complete the study

Laborértékek

• 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).

Egyéb

• Intentional ketogenic diet in the last week
• Cirrhosis or significant alcohol consumption
• >/= Moderate aortic stenosis, >mild mitral stenosis, > moderate aortic or mitral regurgitation
• Systolic blood pressure <90 mmHg
• Pregnant women

• Stable cardiovascular medical therapy for 2 weeks
• 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.