BridgeMD
The effect of empagliflozin on peripheral microvascular dysfunction in heart failure with preserved ejection fraction
EU CTIS ID: 2022-501682-45-00
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Unable or unwilling to sign informed consent
- Under 18 years of age
- Contra-indication to the use of empagliflozin
- Use of empagliflozin or other SGLT-2 inhibitor at baseline
- 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
See the full eligibility criteria
- 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
- Unable or unwilling to sign informed consent
- Under 18 years of age
- Contra-indication to the use of empagliflozin
- Use of empagliflozin or other SGLT-2 inhibitor at baseline
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.