Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

Heart Failure Clinical Trial

— KINETICS2  

Official title:

Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04594265
• Other study ID #: KETO-KINETICS 2 1-10-72-23-20
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2022
• Source: University of Aarhus
• Contact: Kristian H Christensen, MD
• Phone: +4578452029
• Email: krstchri[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40%

Exclusion Criteria: Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent

Related Conditions & MeSH terms

• Heart Failure
• Ketosis

Intervention

Dietary Supplement:
• KetoneAid KE4 Pro Monoester
A dietary supplement containing ketone monoester.
• Science in Sport Go Enegy
Dosis isocaloric to the KetoneAid Arm

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output (L/min)	Change in Cardiac output measured by Swann-Ganz Catherization during study period,	3 hours - Area under the curve
Secondary	Left Ventricular Ejection Fraction	Change in LVEF measured by echocardiography during study periode	3 hours - Area under the curve
Secondary	Blood Ketones	Change in blood Ketones measured by venous blood samples	3 hours
Secondary	Blood pH	Change in venous blood pH during the study period	3 hours