SGLT2 inhibitors and vascular complications after lower limb revascularization.
Ocena powikłań Naczyniowych u pacjentów Poddanych Rewaskularyzacji Obwodowej: wpływ inhibitorów SGLT-2 The Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors
This study will test whether people with peripheral arterial disease who took SGLT2 inhibitors around the time of lower limb revascularization have different rates of major heart or limb problems over the following year compared with those who did not take these drugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wroclaw Medical University Academic / other |
| Locations | 1 site (Wroclaw, Lower Silesian Voivodeship) |
| Trial ID | NCT07157475 on ClinicalTrials.gov |
What this trial studies
This is an observational study of patients with peripheral arterial disease who underwent lower limb revascularization at three vascular surgery departments in Poland. Investigators will extract demographic and clinical data from hospital records and contact patients (or family members) by telephone at 30 days, 3 months, and 1 year to document major adverse cardiac events (3-point MACE), major adverse limb events (MALE), and use of SGLT2 inhibitors. Patients who used SGLT2 inhibitors for at least three months before the procedure or who started them immediately after the procedure will be compared to patients who did not receive these drugs. The primary analysis compares the incidence of predefined MACE and MALE events during the year following the index revascularization.
Who should consider this trial
Good fit: Adults with peripheral arterial disease who had a lower limb revascularization (open or endovascular), have at least 30 days and up to one year of follow-up information available, and whose SGLT2 inhibitor exposure status is known are ideal candidates.
Not a fit: Patients whose procedure was performed for vascular injury, whose amputations were for non-ischemic causes, those with planned non-lower-limb revascularization at discharge, or those without reliable follow-up information are unlikely to be eligible or to benefit from the analysis.
Why it matters
Potential benefit: If SGLT2 inhibitors are linked to fewer heart or limb events after revascularization, the results could help clinicians choose medications that reduce post-procedure complications.
How similar studies have performed: Large trials have shown SGLT2 inhibitors reduce some cardiovascular and renal outcomes in diabetes and heart failure populations, but their specific effects on limb outcomes after peripheral revascularization are not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Peripheral vascular procedure ( Conventional surgical procedure or minimally invasive procedure) due to acute or chronic ischemia * Use of SGLT2 inhibitors (applies only to the group exposed to flozins) for at least 3 months prior to the vascular procedure (the indication for initiating the drug is irrelevant: chronic kidney disease \[CKD\] / cardiac reasons / diabetes), or immediately after the vascular procedure * Ability to determine the patient's outcomes within a minimum of 30 days up to 1 year following the vascular procedure Exclusion Criteria: * Vascular injury as the reason for the procedure * Amputation due to causes other than ischemia (e.g., cancer, neuropathy, trauma without coexisting ischemia) * Planned revascularization procedure other than for the lower limbs at the time of hospital discharge (e.g., coronary or carotid arteries) * Planned ischemia-related amputation or reoperation of the operated limb at the time of hospital discharge * Planned other major surgical procedure with high cardiovascular risk at the time of hospital discharge
Where this trial is running
Wroclaw, Lower Silesian Voivodeship
- Wroclaw Medical University — Wroclaw, Lower Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Edyta Sutkowska, M.D., Ph.D.
- Email: edyta.sutkowska@umw.edu.pl
- Phone: 48503077016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.