Empagliflozin for Peripheral Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Microvascular Dysfunction
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring Heart failure, Empagliflozin, Jardiance, microvascular disease, microvascular function
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Maastricht University HospitalRecruiting
Arms of the Study
Arm 1
Experimental
heart failure with preserved ejection fraction
Empagliflozin 10mg, tablet, once daily