ProtocolInternational Journal of Clinical Trials
Publication: Coronary artery disease treatment strategies and long-term renal function: rationale and design of the cardiorenal study
Int J Clin Trials. 2026.DOI10.18203/2349-3259.ijct20262800
Abstract
Background Treatment strategies for coronary artery disease (CAD), namely coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) and optimized medical therapy (OMT), have well established cardiovascular outcomes, but their long-term effects on renal function remain underexplored. Patients with chronic kidney disease (CKD) are frequently underrepresented in large trials, and renal endpoints are usually treated as markers of cardiovascular risk rather than as outcomes in their own right. This article reports the rationale and design of a study evaluating the long-term renal impact of these strategies.
Methods Single-centre, registry-based cohort study using the Medicine, Angioplasty or Surgery Study (MASS) registry, reported per the STROBE Statement. Eligible patients have stable multivessel CAD, preserved left ventricular function and annual serum creatinine over more than five years, and received OMT, CABG or PCI. The primary outcome is the longitudinal change in estimated glomerular filtration rate (eGFR) over five years; secondary outcomes are new-onset CKD, advanced CKD, renal replacement therapy and mortality. Renal-function trajectories will be modelled with generalized additive models for location, scale and shape (GAMLSS) including a random intercept per patient; time-to-event outcomes with Cox models adjusted for age, sex, diabetes, hypertension and baseline renal function. The cohort has been assembled and the vital-status update completed; outcome analyses are ongoing and will be reported separately.
Conclusions By positioning renal function as a primary outcome, this study may generate evidence to integrate cardiovascular and renal risk into treatment selection for stable multivessel CAD. Trial Registration: The study is registered at ClinicalTrials.gov (NCT07195747).
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Affiliations
- Division of Clinical Cardiology, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil
- Adamantina University Center (UniFAI), Adamantina, Brazil
