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Completed

NCT Number: NCT05236335

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.

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Acid-Base Imbalance Acidosis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Ketonemia Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Insulin treatment, inability to give informed consent

Treatment and study plan

Ketone ester

Dietary Supplement

Commercially available ketone supplement

Placebo drink

Dietary Supplement

Isocaloric placebo

Primary outcomes

  1. Cardiac Output (L/min)

    Time frame: 14 days ketone ester treatment

    Right heart catheterization

Secondary outcomes

  1. Pulmonal wedge capillary Pressure (PCWP)

    Time frame: 14 days ketone ester treatment

    Right heart catheterization

  2. Exercise capacity (METs)

    Time frame: 14 days ketone ester treatment

    Cardiopulmonary exercise test

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: KETO-HFpEF

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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