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.

University of Aarhus1 site in 1 country24 target enrollmentFebruary 1, 2022

ConditionsHeart Failure With Preserved Ejection Fraction Diabetes Mellitus, Type 2 Ketonemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure With Preserved Ejection Fraction
Sponsor: University of Aarhus
Enrollment: 24
Locations: 1
Primary Endpoint: Cardiac Output (L/min)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2022

End Date

June 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

Eligibility Criteria

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:
•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.