Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.
KETO-HFpEF
1 other identifier
interventional
24
1 country
1
Brief Summary
Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF). In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedOctober 10, 2023
December 1, 2021
1.4 years
December 2, 2021
October 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiac Output (L/min)
Right heart catheterization
14 days ketone ester treatment
Secondary Outcomes (2)
Pulmonal wedge capillary Pressure (PCWP)
14 days ketone ester treatment
Exercise capacity (METs)
14 days ketone ester treatment
Study Arms (2)
Ketone ester
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- LVEF \> 40 %
- a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction
- age ≥ 18 years old,
- one of the following criteria (a-d) should be fulfilled:
- Echocardiographic signs of diastolic dysfunction E/e' \> 8
- Septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s
- Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \> 4 cm
- NT-proBNP \> 125 pg/ml.
You may not qualify if:
- Insulin treatment, inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, 8200, Denmark
Related Publications (1)
Gopalasingam N, Berg-Hansen K, Christensen KH, Ladefoged BT, Poulsen SH, Andersen MJ, Borlaug BA, Nielsen R, Moller N, Wiggers H. Randomized Crossover Trial of 2-Week Ketone Ester Treatment in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction. Circulation. 2024 Nov 12;150(20):1570-1583. doi: 10.1161/CIRCULATIONAHA.124.069732. Epub 2024 Aug 20.
PMID: 39162035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2021
First Posted
February 11, 2022
Study Start
February 1, 2022
Primary Completion
June 15, 2023
Study Completion
June 15, 2023
Last Updated
October 10, 2023
Record last verified: 2021-12