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Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19 (KetoCOVID)

S

Steno Diabetes Centers

Status

Completed

Conditions

COVID-19

Treatments

Dietary Supplement: Placebo
Dietary Supplement: D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester

Study type

Interventional

Funder types

Other

Identifiers

NCT04573764
H-20021500

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

12 participants in 2 patient groups, including a placebo group

D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester
Active Comparator group
Treatment:
Dietary Supplement: D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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