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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05236335

Acronym

KETO-HFpEF

Enrollment

Registered

2022-02-11

Start date

2022-02-01

Completion date

2023-06-15

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTKetone ester

Commercially available ketone supplement

DIETARY_SUPPLEMENTPlacebo drink

Isocaloric placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac Output (L/min)	14 days ketone ester treatment	Right heart catheterization

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026