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Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure (KINETICS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594265
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Kristian Hylleberg Christensen, Aarhus University Hospital

Brief Summary:
We aim to investigate the hemodynamic effects of weight-adjusted dosing of 3-OHB Monoester en patients with chronic heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Ketosis Dietary Supplement: KetoneAid KE4 Pro Monoester Dietary Supplement: Science in Sport Go Enegy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients are studied in a randomized single-blind cross-over design.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3-OHB Monoester
Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)
Dietary Supplement: KetoneAid KE4 Pro Monoester
A dietary supplement containing ketone monoester.

Placebo Comparator: Placebo Treatment
Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.
Dietary Supplement: Science in Sport Go Enegy
Dosis isocaloric to the KetoneAid Arm

Active Comparator: 3-OHB Monoester in presence of low-dose insulin clamp
Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism
Dietary Supplement: KetoneAid KE4 Pro Monoester
A dietary supplement containing ketone monoester.




Primary Outcome Measures :
  1. Cardiac Output (L/min) [ Time Frame: 5 hours ]
    Change in Cardiac output measured by Swann-Ganz Catherization during study period,


Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction [ Time Frame: 5 Hours ]
    Change in LVEF measured by echocardiography during study periode

  2. Blood Ketones [ Time Frame: 5 hours ]
    Change in blood Ketones measured by venous blood samples

  3. Blood pH [ Time Frame: 5 hours ]
    Change in venous blood pH during the study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594265


Contacts
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Contact: Kristian H Christensen, MD +4526603577 krstchri@rm.dk
Contact: Henrik S Wiggers, DMsci

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Kristian H Christensen, MD    +4526603577    krstchri@rm.dk   
Sponsors and Collaborators
University of Aarhus
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Responsible Party: Kristian Hylleberg Christensen, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04594265    
Other Study ID Numbers: KETO-KINETICS 2 1-10-72-23-20
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristian Hylleberg Christensen, Aarhus University Hospital:
Hemodynamics
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases