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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. (KETO-HFpEF)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ketone ester
Placebo drink
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketone ester

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Cardiac Output (L/min)
Right heart catheterization

Secondary Outcome Measures

Pulmonal wedge capillary Pressure (PCWP)
Right heart catheterization
Exercise capacity (METs)
Cardiopulmonary exercise test

Full Information

First Posted
December 2, 2021
Last Updated
October 6, 2023
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05236335
Brief 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.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction, Diabetes Mellitus, Type 2, Ketonemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketone ester
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester
Intervention Description
Commercially available ketone supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
Isocaloric placebo
Primary Outcome Measure Information:
Title
Cardiac Output (L/min)
Description
Right heart catheterization
Time Frame
14 days ketone ester treatment
Secondary Outcome Measure Information:
Title
Pulmonal wedge capillary Pressure (PCWP)
Description
Right heart catheterization
Time Frame
14 days ketone ester treatment
Title
Exercise capacity (METs)
Description
Cardiopulmonary exercise test
Time Frame
14 days ketone ester treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Exclusion Criteria: Insulin treatment, inability to give informed consent
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Learn more about this 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.

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