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.

Not Applicable

Completed

• Conditions: Ketonemia; Heart Failure With Preserved Ejection Fraction; Diabetes Mellitus, Type 2

• Registration Number: NCT05236335
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-02
• Study Start: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-11
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cardiac Output (L/min)	14 days ketone ester treatment	Right heart catheterization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark