Risk stratification of major adverse cardiovascular events in heart failure patients undergoing coronary artery bypass grafting: an observational multicenter prospective study (PROFILE-HF)

Abstract

Introduction. Coronary artery bypass grafting (CABG) is a primary treatment for patients with coronary artery disease (CAD) and chronic heart failure (CHF) with multivessel atherosclerosis of the coronary arteries. However, major clinical studies demonstrate a persistent high risk of adverse cardiovascular events in this cohort, even after revascularization. Growth Differentiation Factor 15 (GDF-15), according to several studies, has high prognostic value in patients with CHF and CAD, including those who have undergone CABG. This finding requires confirmation in specially designed prospective multicenter studies. Aim: To present a study protocol with the primary aim of developing a method for assessing the risk of adverse cardiovascular events in patients with coronary artery disease (CAD) and chronic heart failure (CHF) who have undergone coronary artery bypass grafting (CABG), taking into account preoperative growth differentiation factor-15 (GDF-15) levels. Material and Methods. This is a multicenter, observational, prospective study of the clinical course and outcomes of patients with CAD and CHF who have undergone CABG. To ensure a representative sample, at least 160 patients will be enrolled. The study will have a 12-month follow-up period. Expected results. The study will include collecting patient complaints and anamnesis, performing a physical examination, a six minute walk test, and analyzing the results of general clinical laboratory and instrumental examinations. GDF-15 concentrations will be analyzed centrally at the Cardiology Research Institute, Tomsk NRMC laboratory. Treatment adherence will be assessed using the Morisky-Green questionnaire at the enrollment visit and after 12 months of follow-up. The study will be followed for 12 months. Prospective follow-up will assess the development of a combined primary and secondary endpoint, including death and adverse cardiovascular events. Conclusion. PROFILE-HF is the first multicenter prospective study specifically designed to evaluate the prognostic significance of preoperative GDF-15 concentrations in patients with coronary artery disease and CHF who underwent CABG.