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Active Not Recruiting
NCT07431515
Long-term Risk of Cardiovascular Disease in Living Kidney Donors
Conditions: Living Donor Nephrectomy, Living Kidney Donation, Living Kidney Donor, Living Kidney Donors, Cardiovascular Disease, Major Adverse Cardiovascular Events (MACE), Mortality
Sex: All
Ages: 18 Years – 105 Years
Healthy volunteers: Yes
Enrollment: 50000
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
The investigative team will conduct a population-based, matched retrospective cohort study across Ontario, Alberta, and British Columbia using linked administrative healthcare databases to evaluate the long-term risk of major adverse cardiovascular events (MACE) among living kidney donors compared with matched healthy nondonors. Living kidney donors who donated between 1992 and 2024 will be included and matched 1:10 to a carefully selected population of nondonors based on key demographic and clinical characteristics. The primary outcome is a composite of cardiovascular death, hospital admission for myocardial infarction, or hospital admission for ischaemic stroke. Secondary outcomes will examine each component of the composite separately and all-cause mortality. The results will provide evidence to inform clinical guidelines, support informed decision-making for potential donors and recipients, and guide counselling by transplant clinicians.
Eligibility Criteria
\*Donors\* Inclusion Criteria: Living kidney donors who underwent donor nephrectomy in Ontario, Alberta, and British Columbia, Canada, between July 1, 1992, and March 31, 2024 are eligible to enter the study.
Exclusion Criteria:
* Any person with data errors in their database records (such as missing or invalid age; it is expected to exclude very few persons for these reasons). Data errors also include evidence of prior dialysis or a prior solid organ transplant, as such individuals are not eligible to become donors.
* Any person who was not a permanent resident of the province (i.e., patient lives outside of the province, and only came to the province to donate a kidney to the intended recipient). This will include anyone who is not eligible for the province's health insurance plan, anyone whose date of last contact in the databases is less than 1 year after the cohort entry date, and any person without a physician visit in the last 1-year.
* Any person who is \
Source: ClinicalTrials.gov (NCT07431515). StuddyBuddy aggregates publicly available trial information.