Clinical Trials Logo

Clinical Trial Summary

Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present study, healthy test subjects and patients with heart failure with reduced ejections fraction will be investigated in a randomized cross-over design with ketone infusions and placebo. Myocardial efficiency and hemodynamics will be evaluated.


Clinical Trial Description

The prevalence of patients with heart failure and reduced ejection fraction (HFrEF) is 1-2%, and the lifetime risk of heart failure at age 55 years is approximately 30%. Despite advances in treatment, hospitalization rate and mortality remains high. It is well known that myocardial metabolism changes during development of HFrEF, and may contribute to contractile dysfunction. However, the myocardium can be considered an omnivore regarding substrate utilization, conferring an important adaptive property. Hence, it metabolizes either glucose, lipids, lactate, amino acids or ketones (3-hydroxybutyrate) depending on substrate availability, hormonal status and cardiac demands. These substrates differ with regard to myocardial energy efficiency (MEE) (cardiac work related to oxygen consumption). Since high MEE is associated with a better prognosis in HFrEF, manipulating substrate uptake could be a new treatment modality in heart failure patients.

Recently, it was shown that the human myocardium increases 3-hydroxybutyrate (3-OHB) metabolism during development of HFrEF. These changes may be beneficial as 3-OHB could increase myocardial efficiency and lower oxidative stress by scavenging free radicals. However, until now this has not been investigated in clinical trials, and the effect of 3-OHB on cardiac function, oxygen consumption and perfusion remains undetermined in HFrEF patients.

In the present study the investigators will evaluate whether elevated circulating 3-OHB affect myocardial oxygen consumption, MEE and perfusion in healthy subjects and patients with HFrEF, and whether 3-OHB affect hemodynamics and contractile function.

10 healthy test subjects and 20 HFrEF patients will be subjected to placebo and 3-OHB infusion in a randomized cross-over design. Acetate-PET, echocardiography and right sided heart catheterization will be applied. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03073356
Study type Interventional
Source University of Aarhus
Contact
Status Completed
Phase Phase 2
Start date March 17, 2017
Completion date November 16, 2017

See also
  Status Clinical Trial Phase
Withdrawn NCT03227393 - The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG N/A
Recruiting NCT04528004 - Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure Early Phase 1
Recruiting NCT04703842 - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Phase 1/Phase 2
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Completed NCT05475028 - Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
Not yet recruiting NCT06240403 - Digoxin and Senolysis in Heart Failure and Diabetes Mellitus Phase 2
Not yet recruiting NCT05988749 - Digital Remote Home Monitoring for Heart Failure N/A
Recruiting NCT04950218 - The Psoriasis Echo Study
Suspended NCT04701112 - Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure N/A
Completed NCT03305692 - ECG Belt vs. Echocardiographic Optimization of CRT N/A
Recruiting NCT05933083 - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation N/A
Enrolling by invitation NCT03903107 - The Fluoroless-CSP Trial Using Electroanatomic Mapping N/A
Withdrawn NCT04872959 - TRANSFORM Heart Failure With Reduced Ejection Fraction N/A
Completed NCT02920918 - Treatment of Diabetes in Patients With Systolic Heart Failure Phase 4
Completed NCT02334891 - Kyoto Congestive Heart Failure Study
Recruiting NCT03553303 - Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin Phase 4
Recruiting NCT04083690 - Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients N/A
Recruiting NCT03830957 - Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker N/A
Recruiting NCT06121323 - Physiological Effects of Lactate in Individuals With Chronic Heart Failure N/A
Completed NCT03351283 - Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure N/A