Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol (KETO-BD)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
1,3-Butanediol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria: Chronic HF: NYHA class II-III, LVEF <40%. Negative urine-HCG for women with childbearing potential. Age ≥18 years. 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.
Sites / Locations
- Dept. of Cardiology, Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1,3-Butanediol
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Cardiac output
As measured by LVOT VTI and HR
Secondary Outcome Measures
Stroke volume
Heart rate
LVEF
Changes in circulating 3-OHB
Changes in FFA
Full Information
NCT ID
NCT05768100
First Posted
March 2, 2023
Last Updated
April 17, 2023
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05768100
Brief Title
Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
Acronym
KETO-BD
Official Title
Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Heart Failure (HF) is a major public health issue affecting 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is high. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.
In a first-in-man study we have recently discovered that 3-OHB-infusion increases cardiac output by 2 L/min (40% relative increase) and left ventricular (LV) ejection fraction (LVEF) by 8% in absolute numbers in patients with HF and reduced LVEF (HFrEF).
1,3-Butanediol (BD) serves as a potential nutritional supplement in providing long-lasting ketosis as a treatment option in heart disease. Whether BD provides similar hemodynamic effects as ketone monoester remains unknown.
Hypothesis Oral BD increases cardiac output and LV function in patients with HFrEF.
Aims To investigate the acute hemodynamic effects of weight-adjusted oral BD supplements in patients with HFrEF.
Design In a randomized, single-blind, placebo-controlled, crossover design, 12 patients with HFrEF are studied following overnight fast on 2 separate visits in random order: 1) during intake of BD (HVMN, San Francisco, California, USA) and during placebo.
Methods Transthoracic echocardiography, non-invasive blood pressure, and venous blood samples are obtained every 60 minutes from baseline until 6 hours following BD ingestion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1,3-Butanediol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
1,3-Butanediol
Other Intervention Name(s)
Ketone-IQ (HVMN)
Intervention Description
1,3-Butanediol
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Isovolumic placebo
Primary Outcome Measure Information:
Title
Cardiac output
Description
As measured by LVOT VTI and HR
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Stroke volume
Time Frame
6 hours
Title
Heart rate
Time Frame
6 hours
Title
LVEF
Time Frame
6 hours
Title
Changes in circulating 3-OHB
Time Frame
6 hours
Title
Changes in FFA
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic HF: NYHA class II-III, LVEF <40%. Negative urine-HCG for women with childbearing potential. Age ≥18 years.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristoffer Berg-Hansen
Phone
+4560540700
Email
krisbe@rm.dk
Facility Information:
Facility Name
Dept. of Cardiology, Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristoffer Berg-Hansen, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
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