Heart Failure, Systolic Clinical Trial
— KETO-COXOfficial title:
Effects of Ketones and Niacin in Heart Failure Patients
Verified date | October 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 effects are currently unknown, but could involve prostaglandin-release. 3-OHB is the endogenous ligand for the G protein-coupled receptor hydroxy-carboxylic acid 2 (HCA2) receptor. This receptor has proven downstream effects on cAMP and systemic effects via release of prostaglandins. In this present study we will investigate the cardiovascular effects of HCA2-receptor stimulation in heart failure patients.
Status | Completed |
Enrollment | 12 |
Est. completion date | September 3, 2021 |
Est. primary completion date | September 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Output | L/min | 3 hours | |
Secondary | Mixed venous saturation | SvO2 | 3 hours | |
Secondary | Pulmonary wedge pressure | PWR | 3 hours | |
Secondary | Left ventricular ejection fraction | EF | 3 hours | |
Secondary | Circulating prostaglandin levels | prostaglandins | 3 hours |
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