Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
The Effect of Empagliflozin on Peripheral Microvascular Dysfunction in Heart Failure With
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)
Status | Recruiting |
Enrollment | 48 |
Est. completion date | February 13, 2025 |
Est. primary completion date | August 13, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Hospital | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | baseline bloodflow and area under the curve | as measured by LASCA | Change from baseline to after 3 months | |
Secondary | Serum ketone levels in mmol/L | Serum ketone levels in mmol/L | Change from baseline to after 3 months | |
Secondary | EQ5D-5L questionnaire score | index value, ranging from 1 to -0.5. a higher value is a better outcome analogue scale and single index value | Change from baseline to 3 months | |
Secondary | EQ5D-5L questionnaire score | visual analogue scale, ranging from 1 to 100, a higher value is a better outcome | Change from baseline to 3 months |
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