Empagliflozin for Peripheral Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

NCT06046612 | Unknown Phase 4

• 1 other identifier: 20225016824500
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this low-intervention clinical trial is to learn about the effect of the drug Empagliflozin in patients with heart failure with preserved ejection fraction. The main questions it aims to answer are:

• What is the effect of treatment with Empagliflozin after 3 months on peripheral microvascular function
• Do clinical correlates for worse microvascular function exist, and thus identify patients that could possibly benefit most from empagliflozin treatment Patients will use Empagliflozin, prescribed by their treating physician. Before the start of treatment and after 3 months they will be asked to
• Fill out a quality of life questionnaire
• Draw 4 tubes of blood
• Undergo non-invasive measurement of the blood flow of the microvasculature in the forearm (using laser speckle contrast analysis)

Conditions

Heart Failure With Preserved Ejection Fraction; Microvascular Dysfunction

Keywords

Heart failure; Empagliflozin; Jardiance; microvascular disease; microvascular function

Outcome Measures

Primary Outcomes (1)

• Cutaneous vascular conductance (CVC)

  Skin blood flow (arbitrary perfusion units, APU) is divided by the mean arterial pressure to yield the CVC.

  Change from baseline to 3 months

Secondary Outcomes (4)

• baseline bloodflow and area under the curve

  Change from baseline to after 3 months

• Serum ketone levels in mmol/L

  Change from baseline to after 3 months

• EQ5D-5L questionnaire score

  Change from baseline to 3 months

• EQ5D-5L questionnaire score

  Change from baseline to 3 months

Study Arms (1)

heart failure with preserved ejection fraction

EXPERIMENTAL

Empagliflozin 10mg, tablet, once daily

Drug: Participants receive 10mg Empaglifozin once daily on prescription from their treating physician. This is not an intervention in this trial, but part of their normal HFpEF treatment

Interventions

Participants receive 10mg Empaglifozin once daily on prescription from their treating physician. This is not an intervention in this trial, but part of their normal HFpEF treatment DRUG

The investigational medicinal product investigated in this trial (empagliflozin) is authorised for use in the European Union by the European Medicines Agency and will be used in accordance with the terms of the marketing authorization. The treating physician (cardiologist) will determine the indication for empagliflozin use, discuss the benefits and risks with the patient, prescribe the drug, and provide follow up after starting the drug, according to normal clinical practice. The study participants are not assigned to a particular therapeutic strategy decided by the clinical trial protocol.

Also known as: Jardiance

heart failure with preserved ejection fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HFpEF diagnosis according to the ESC 2021 Guidelines for the diagnosis and treatment of acute and chronic heart failure Symptoms and signs of HF LVEF ≥ 50% (on any imaging modality) Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/ raised LV filling pressures, including raised natriuretic peptides (table 1) OR invasively measured pulmonary capillary wedge pressure (PCWP) of \>15 mmHg (at rest) or ≥25 mmHg (with exercise) or left ventricular end diastolic pressure ≥ 16 mmhg (at rest).
• Ability to understand and speak the Dutch language
• Treatment with empagliflozin 10mg once daily is planned to be started by the treating physician
• Signed informed consent

You may not qualify if:

• Unable or unwilling to sign informed consent
• Under 18 years of age
• Contra-indication to the use of empagliflozin Severe kidney disease (Glomerular filtration rate\< 20 ml/min) Severe liver insufficiency Recent (\<12 months) or planned major surgery (Including coronary artery bypass grafting, cardiac valve replacement) Severe acute disease (\< 12 months) (Including acute coronary syndrome, TIA/CVA) Pregnancy
• Use of empagliflozin or other SGLT-2 inhibitor at baseline
• Known hypersensitivity to empagliflozin, acetylcholine, sodium nitroprusside or insulin
• Insulin dependent patients (Fasting conditions cause a risk of ketoacidosis in these patients).
• Subjects currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study.
• Any condition that interferes with the correct execution of the LASCA measurements (patient is unable to keep arms motionless during the measurements, any condition that does not allow disposables to be attached to the forearm skin)
• Any other reason that makes it undesirable for patient to use empagliflozin according to the researcher / treating physician

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Hospital

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Related Publications (1)

• Mourmans SGJ, Achten A, Hermans R, Scheepers MJE, D'Alessandro E, Swennen G, Woudstra J, Appelman Y, Goor HV, Schalkwijk C, Knackstedt C, Weerts J, Eringa EC, van Empel VPM. The effect of empagliflozin on peripheral microvascular dysfunction in patients with heart failure with preserved ejection fraction. Cardiovasc Diabetol. 2025 Apr 25;24(1):182. doi: 10.1186/s12933-025-02679-8.

  PMID: 40281528 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Sanne GJ Mourmans, Drs.

CONTACT

+31433871612; sanne.mourmans@mumc.nl

Vanessa PM van Empel, Dr.

CONTACT

vanessa.van.empel@mumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receive 10mg Empaglifozin once daily on prescription from their treating physician. This is not an intervention in this trial, but part of their normal HFpEF treatment. At the start of the study patients will undergo the LASCA measurements. A very small amount of acetylcholine, nitroprusside and insulin will be applied to the skin of the forearm, to stimulate the bloodflow during LASCA. After 3 months of use of Empagliflozin the LASCA measurement will be repeated. Furthermore, at each visit 4 tubes of blood will be drawn for biobanking, and patients will be asked to fill out a quality of life questionnaire. During the trial, patients will be monitored in routine clinical care as indicated by their treating physician.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: September 21, 2023
• Study Start: February 13, 2023
• Primary Completion: August 13, 2024
• Study Completion: February 13, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

NL (1)