2022-501682-45-00CompletedPhase 4
The effect of empagliflozin on peripheral microvascular dysfunction in heart failure with preserved ejection fraction
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Dec 2022
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 22 Aug 2022
- Start date
- 13 Feb 2023
- Lead sponsor
- University Hospital Maastricht
- Diseases
- Heart failure
- EU CT number
- 2022-501682-45-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 48
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Age
- Under 18 years of age
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Maastricht | Maastricht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.