Status:
UNKNOWN
Empagliflozin for Peripheral Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Heart Failure With Preserved Ejection Fraction
Microvascular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Detailed Description
Heart failure (HF) with preserved ejection fraction (HFpEF), is an important public health problem with a poor prognosis and many people are affected by it. Microvascular dysfunction (MVD) is thought ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 13 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06046612
Start Date
February 13 2023
End Date
February 13 2025
Last Update
September 21 2023
Active Locations (1)
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1
Maastricht University Hospital
Maastricht, Limburg, Netherlands, 6229 HX