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NCT05236335 Clinical Trial

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.

Diabetes Mellitus, Type 2 Clinical Trial

— KETO-HFpEF  

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05236335
Other study ID # 0059
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date June 15, 2023

Study information
Verified date December 2021
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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: 1. Echocardiographic signs of diastolic dysfunction E/e' > 8 2. Septal e ´< 7 cm/s and/or lateral e ´ < 10 cm/s 3. Left atrium volume index =34 mL/m2 and/or left atrial diameter > 4 cm 4. NT-proBNP > 125 pg/ml. Exclusion Criteria: - Insulin treatment, inability to give informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Ketone ester
Commercially available ketone supplement
• Placebo drink
Isocaloric placebo

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) Right heart catheterization 14 days ketone ester treatment
Secondary Pulmonal wedge capillary Pressure (PCWP) Right heart catheterization 14 days ketone ester treatment
Secondary Exercise capacity (METs) Cardiopulmonary exercise test 14 days ketone ester treatment
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