Status:
COMPLETED
Effects of Ketones and Niacin in Heart Failure Patients
Lead Sponsor:
University of Aarhus
Conditions:
Heart Failure, Systolic
Ketonemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. The mechanisms behind these marked hemodynamic eff...
Detailed Description
Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. HF is responsible for 1-2% of all healthcare expenditur...
Eligibility Criteria
Inclusion
- Chronic heart failure, Age ≥ 18 years old, LVEF ≤40%, New York Heart Association (NYHA) classification 2-3, Negative urine-HCG for women of childbearing potential, Ability to understand the written patient information and to give informed consent.
Exclusion
- Symptomatic cardiac valve disease, Signs or history of major myocardial infarction (STEMI) within 1 month, Insulin treatment, Other disease or treatment making subject unsuitable for study participation as judged by the investigator.
- Significant liver disease (defined by serum levels of alanine aminotransferase (ALAT) above 3 x upper limit of normal).
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04703361
Start Date
February 15 2021
End Date
September 3 2021
Last Update
December 3 2021
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200