Clinical trial NCT04442555: Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
Official title: Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Heart Failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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 \*
* 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.

Primary outcomes:
measure: Cardiac Output (L/min)
timeFrame: 3 hours - Area under the curve
measure: Left Ventricular Ejection Fraction
timeFrame: 3 hours - Area under the curve
Secondary outcomes:
measure: Left Ventricular Outflow Tract Velocity Time Integral (cm)
timeFrame: 3 hours - Area under the curve
measure: Left Ventricular Filling Pressure (mmHg)
timeFrame: 3 hours - Area under the curve
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: