Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure (KETO-AHF1)
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|ClinicalTrials.gov Identifier: NCT04442555|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : July 18, 2022
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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
To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements.
The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.
The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.
|Condition or disease||Intervention/treatment||Phase|
|Acute Heart Failure||Dietary Supplement: HVMN Ketone Ester Dietary Supplement: Maltodextrin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||March 30, 2023|
|Estimated Study Completion Date :||March 30, 2023|
Experimental: 3-Hydroxybutyrate treatment
HVMN Ketone Ester 0,5 g / kg
Dietary Supplement: HVMN Ketone Ester
Commercially available ketone supplement
Placebo Comparator: Placebo Treatment
Maltodextrin-base isocaloric placebo
Dietary Supplement: Maltodextrin
Commercially available maltodextrin supplement
- Cardiac Output (L/min) [ Time Frame: 3 hours - Area under the curve ]Right Heart Catherization
- Left Ventricular Ejection Fraction [ Time Frame: 3 hours - Area under the curve ]Echocardiography
- Left Ventricular Outflow Tract Velocity Time Integral (cm) [ Time Frame: 3 hours - Area under the curve ]Echocardiography
- Left Ventricular Filling Pressure (mmHg) [ Time Frame: 3 hours - Area under the curve ]Right Heart Catherization
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Hospitalized with worsening HF or de novo diagnosis of HF
- LVEF < 50%
- Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics.
- Cardiogenic shock
- Systolic Blood Pressure <85 mmHg
- Acute myocardial infarction other than type II <5 days prior to randomization *
- Severe uncorrected cardiac valve disease
- Expected or possible need for hemodialysis as judged by the investigator
- Ongoing inotropic treatment
- Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator.
- Ongoing, severe infection
- Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/min or intubated)
- Atrial Fibrillation with heart >120 beats per minute
Inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort.
- If suspected or confirmed acute myocardial infarction as cause of acute heart failure, patients can be recruited 5 days after hospitalization in the absence of malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant residual angina pectoris.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442555
|Contact: Kristian H Christensen, MDfirstname.lastname@example.org|
|Contact: Henrik S Wiggers, DMsci|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Kristian H Christensen, MD email@example.com|
|Responsible Party:||Kristian Hylleberg Christensen, MD, Principal Investigator, University of Aarhus|
|Other Study ID Numbers:||
|First Posted:||June 22, 2020 Key Record Dates|
|Last Update Posted:||July 18, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|