Status:
UNKNOWN
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
Lead Sponsor:
University of Aarhus
Conditions:
Acute Heart Failure
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 incre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04442555
Start Date
February 1 2020
End Date
March 30 2023
Last Update
July 18 2022
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200