The effect of empagliflozin on peripheral microvascular dysfunction in heart failure with preserved ejection fraction
Key facts
- Where
- Maastricht, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- University Hospital MaastrichtMaastricht, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Maastricht
- Trial code
- EU 2022-501682-45-00
- Record updated
- 2022. december 1.
- Original description
The primary objective of this study is to evaluate the effect of treatment with the SGLT-2 inhibitor empagliflozin after 3 months on peripheral microvascular function, defined as the cutaneous vascular conductance (CVC) in the forearm skin, measured by laser speckle contrast analysis (LASCA) during iontophoresis of achetylcholin, insulin and nitroprusside, in HFpEF patientsRead full original descriptionShow less
The primary objective of this study is to evaluate the effect of treatment with the SGLT-2 inhibitor empagliflozin after 3 months on peripheral microvascular function, defined as the cutaneous vascular conductance (CVC) in the forearm skin, measured by laser speckle contrast analysis (LASCA) during iontophoresis of achetylcholin, insulin and nitroprusside, in HFpEF patients
Inclusion: HFpEF diagnosis according to the ESC 2021 Guidelines for the diagnosis and treatment of acute and chronic heart failure; 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: Use of empagliflozin or other SGLT-2 inhibitor at baseline; Subjects currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study; Insulin dependent patients (Fasting conditions cause a risk of ketoacidosis in these patients); 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); Under 18 years of age; Unable or unwilling to sign informed consent; Contra-indication to the use of empagliflozin; Any other reason that makes it undesirable for patient to use empagliflozin according to the researcher / treating physician.