Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors

NCT07157475 | Recruiting

• 1 other identifier: BW-24/2025
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study is observational and involves patients (pts) with peripheral arterial occlusive disease (PAD) who have undergone lower limb revascularization procedures. Patients who are at least one year post-procedure will be contacted by phone and asked whether any cardiovascular complications occurred during that period, specifically major adverse cardiovascular events (MACE) or major adverse limb events (MALE), and whether they had been taking sodium-glucose co-transporter 2 inhibitors (SGLT2-i, "flozins") during the year following the procedure. The results from the group of pts who, for any reason, received SGLT2-i treatment after the vascular procedure (including those who had initiated treatment before surgery) will be compared to the results from the group of patients who did not receive such treatment, with regard to the occurrence of the aforementioned complications.

Conditions

Peripheral Arterial Disease(PAD)

Keywords

flozins; SGLT2i; peripheral arterial disease; revascularisation; MACE; MALE

Outcome Measures

Primary Outcomes (1)

• MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE

  MACE is defined as a composite of : Non-fatal myocardial infarction (MI); Non-fatal stroke involving the central nervous system (CNS); or Cardiovascular death MALE is defined as a composite of : Untreated loss or deterioration of patency in a previously revascularized vessel; Repeat intervention in a revascularized segment due to impaired patency, or Amputation (above or below the knee) of the revascularized limb Unit of Measure: Number of participants with at least one event

  12 months from the vascular intervention

Secondary Outcomes (6)

• Non-fatal Myocardial Infarction (MI)

  12 months from the vascular intervention

• Non-fatal Stroke Involving the Central Nervous System (CNS)

  12 months from the vascular intervention

• Cardiovascular Death

  12 months from the vascular intervention

• Loss or Deterioration of Patency in a Previously Revascularized Vessel

  12 months from the vascular intervention

• Repeat intervention in a revascularized segment due to impaired patency

  12 months from the vascular intervention

Other Outcomes (7)

• Additional secondary endpoint- Surgical site infection (SSI)

  12 months from vascular intervention

• Additional secondary endpoint- Significant bleeding

  12 months from vascular intervention

• Additional secondary endpoint- Kidney injury

  12 months from vascular intervention

Study Arms (2)

Patients after vascular surgery treated with flozins

Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and, for any reason, were treated with SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.

Drug: Treatment with SGLT2 inhibitors (flozins)

Patients after vascular surgery with no exposure to flozins (controls)

Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and were not exposed to SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.

Interventions

Treatment with SGLT2 inhibitors (flozins) DRUG

Patients received SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) as part of their routine clinical care during the 12-month follow-up period after elective or urgent lower limb revascularization procedures. The study does not assign treatment; medication use occurred independently of the study protocol.

Patients after vascular surgery treated with flozins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The analyzed cases will involve patients from three major vascular clinics located in Wrocław, Poznań, and Warsaw.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Poznan University of Medical Sciences: collaborator
• Military Institute of Medicine National Research Institute: collaborator

Study Sites (1)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Therapeutics; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Edyta Sutkowska, Ph.D

  Wroclaw Medical University

  STUDY CHAIR

Central Study Contacts

Edyta Sutkowska, M.D., Ph.D.

CONTACT

48503077016; edyta.sutkowska@umw.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 5, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data (de-identified) and supporting documents will be available upon reasonable request from qualified researchers, starting 6 months after publication of the primary results and for a period of 5 years.
• Access Criteria: Anonymized individual participant data (IPD) may be shared upon reasonable request. Access will be considered for qualified researchers with a valid scientific proposal. Requests will be reviewed by the study team, and a data sharing agreement may be required.

Locations

PL (1)