Status:
COMPLETED
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.
Lead Sponsor:
University of Aarhus
Conditions:
Heart Failure With Preserved Ejection Fraction
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Insulin treatment, inability to give informed consent
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05236335
Start Date
February 1 2022
End Date
June 15 2023
Last Update
October 10 2023
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200