Status:
ENROLLING_BY_INVITATION
Ketones in Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
Duke University
Collaborating Sponsors:
American Heart Association
National Institutes of Health (NIH)
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to understand the effects of a ketone drink on exercise capacity and other cardiovascular parameters in patients with heart failure. In heart failure, patients are limited...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Intentional ketogenic diet in the last week
- Cirrhosis or significant alcohol consumption
- 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).
- 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).
- \>/= Moderate aortic stenosis, \>mild mitral stenosis, \> moderate aortic or mitral regurgitation
- Type 1 diabetes mellitus
- Implant of cardiac resynchronization therapy, cardiac contractility modulation, or barostim device within the previous 3 months.
- Systolic blood pressure \<90 mmHg
- Pregnant women
- 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.
- Participation in another clinical study with an investigational product in the previous 4 weeks prior to enrollment.
- Conditions that may render the patient unable to complete the study
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06195982
Start Date
March 6 2024
End Date
February 1 2027
Last Update
May 18 2025
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710