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

COVID-19 Clinical Trial

— KetoCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573764
• Other study ID #: H-20021500
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Dietary Supplement:
• D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester
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
Taste-matched water

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular ejection fraction	Echocardiography	1 hour
Secondary	Global longitudinal strain	Echocardiography	1 hour
Secondary	Cardiac output	Echocardiography	1 hour
Secondary	Peripheral blood oxygen saturation	Pulse oximetry	5 minutes
Secondary	Venous blood oxygen saturation	blood gas analysis	5 minutes
Secondary	Urine creatinine clearance	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.	12 hours