Clinical trial NCT04573764: Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19
Official title: Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized placebo-controlled double-blinded crossed-over acute intervention study.
Primary purpose: TREATMENT

Brief summary: Based on Chinese studies, cardiac injury occurs in 20-30% of hospitalized patients and contributes to 40% of deaths. There are many possible mechanisms of cardiac injury in COVID-19 patients and increased myocardial oxygen demand and decreased myocardial oxygen supply are likely contributors to increased risk of myocardial infarction and heart failure. Interventions reducing the risk of cardiac injury are needed.

Ketone bodies, such as 3-hydroxybutyrate and acetoacetate, can maintain ATP production in the heart and brain during starvation. It has been suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per ATP-molecule produced. In addition, the reduction in hospitalizations due to heart failure observed in type 2 diabetes patients treated with sodium-glucose cotransporter 2 inhibitors, is suggested to be partly attributable to increased levels of 3-hydroxybutyrate. Infusion with 3-hydroxybutyrate reaching a plasma level of approximately 3 mM had acute beneficial hemodynamic effects in patients with heart failure and in healthy controls in a study by Nielsen et al. Improved haemodynamics and reduced systemic oxygen consumption might be of great benefit in patients with COVID-19.

The primary endpoint is left ventricular ejection fraction. Secondary endpoints are conventional echocardiography parameters, peripheral blood oxygen saturation, venous blood oxygen saturation and urine creatinine clearance.

The study population are twelve previously hospitalized patients with COVID-19

The study design is a randomized placebo-controlled double-blinded crossed-over acute intervention study.


Eligibility criteria: Inclusion Criteria:

- Patients previously hospitalized at hospitals of greater Copenhagen and the Zealand region with a laboratory confirmed diagnosis of COVID-19 \> 18 years of age.

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable to understand and sign "informed consent"
* Diagnosis with chronic obstructive pulmonary disease
* Diagnosis with asthma
* Active treatment with sodium-glucose transporter 2 inhibitors
* eGFR \< 15 ml/min/1.73m2
* insulin-dependent diabetes

Primary outcomes:
measure: Left Ventricular ejection fraction
timeFrame: 1 hour
Secondary outcomes:
measure: Global longitudinal strain
timeFrame: 1 hour
measure: Cardiac output
timeFrame: 1 hour
measure: Peripheral blood oxygen saturation
timeFrame: 5 minutes
measure: Venous blood oxygen saturation
timeFrame: 5 minutes
measure: Urine creatinine clearance
timeFrame: 12 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Please Select
Study officials:
affiliation: University of Copenhagen
name: Tor Biering-Sørensen, MD
role: PRINCIPAL_INVESTIGATOR
References: