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OpenTrials
Completed

NCT Number: NCT04573764

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Please Select, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester

Dietary Supplement

The intervention is D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester and will be bought commercially. As an example: One bottle of "KetoneAid KE4 PRO" with 60 ml contains 30 g D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester. For more information please refer to: https://shop.ketoneaid.com/collections/all/products/ke4-pro. Placebo will be a taste-matched water solution provided by the company. The placebo solution and the active solution will be prepared in identic bottles and investigators will be blinded.

Placebo

Dietary Supplement

Taste-matched water

Primary outcomes

  1. Left Ventricular ejection fraction

    Time frame: 1 hour

    Echocardiography

Secondary outcomes

  1. Global longitudinal strain

    Time frame: 1 hour

    Echocardiography

  2. Cardiac output

    Time frame: 1 hour

    Echocardiography

  3. Peripheral blood oxygen saturation

    Time frame: 5 minutes

    Pulse oximetry

  4. Venous blood oxygen saturation

    Time frame: 5 minutes

    blood gas analysis

  5. Urine creatinine clearance

    Time frame: 12 hours

    Urine will be collected during the two cross-over sessions and urine creatinine will be measured on these two volumes. Creatinine clearance in ml/min/1.73m2 will then be estimated and compared with plasma creatinine for estimating kidney function.

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Acronym: KetoCOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2020
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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