KETO-AHF1: Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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
|
Outcome Measures
Primary Outcome Measures
- Cardiac Output (L/min) [3 hours - Area under the curve]
Right Heart Catherization
- Left Ventricular Ejection Fraction [3 hours - Area under the curve]
Echocardiography
Secondary Outcome Measures
- Left Ventricular Outflow Tract Velocity Time Integral (cm) [3 hours - Area under the curve]
Echocardiography
- Left Ventricular Filling Pressure (mmHg) [3 hours - Area under the curve]
Right Heart Catherization
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Cardiogenic shock
-
Systolic Blood Pressure <85 mmHg
-
Acute myocardial infarction other than type II <5 days prior to randomization *
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Severe uncorrected cardiac valve disease
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Expected or possible need for hemodialysis as judged by the investigator
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Ongoing inotropic treatment
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Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator.
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Ongoing, severe infection
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Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/min or intubated)
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Atrial Fibrillation with heart >120 beats per minute
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Aarhus University Hospital | Aarhus | Denmark | 8200 |
Sponsors and Collaborators
- University of Aarhus
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KETO-AHF1 1-10-72-59-19