A Phase 1 interventional study of HVMN Ketone Ester and Maltodextrin in Acute Heart Failure, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by University of Aarhus · Phase 1, Interventional, and Treatment
Background:
Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure
Objectives:
To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements.
Methods:
The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.
Perspectives:
The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 12 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort.
HVMN Ketone Ester 0,5 g / kg
Dietary Supplement: HVMN Ketone Ester
Maltodextrin-base isocaloric placebo
Dietary Supplement: Maltodextrin
Commercially available ketone supplement
Commercially available maltodextrin supplement
Cardiac Output (L/min)
Right Heart Catherization
Time frame: 3 hours - Area under the curve
Left Ventricular Ejection Fraction
Echocardiography
Time frame: 3 hours - Area under the curve
Left Ventricular Outflow Tract Velocity Time Integral (cm)
Echocardiography
Time frame: 3 hours - Area under the curve
Left Ventricular Filling Pressure (mmHg)
Right Heart Catherization
Time frame: 3 hours - Area under the curve
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University of Aarhus