NCT07480915

Risk Stratification of MACE in Heart Failure Patients Who Undergoing CABG

Risk Stratification of MACE Based on GDF-15 in Heart Failure Patients Who Undergoing Coronary Artery Bypass Grafting: an Observational Multicenter Prospective Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

PROFILE-HF is a multicenter, observational, prospective study of the clinical course and outcomes of chronic heart failure (HF) and coronary artery disease (CAD) in patients undergoing coronary artery bypass grafting (CABG). The objective of the study is to develop a method for assessing the risk of adverse cardiovascular events in patients with CAD and HF who have undergone CABG, based on preoperative GDF-15 concentrations. The study will have a 12-month follow-up period; one in-person visit is planned at the end of the follow-up period. If it is not possible to visit a doctor in person, information will be collected through telephone contact with the patient or his relative or person caring for the patient.

Detailed description

PROFILE-HF is a multicenter, observational, prospective study of the clinical course and outcomes of chronic heart failure (HF) and coronary artery disease (CAD) in patients undergoing coronary artery bypass grafting (CABG). The objective of the study is to develop a method for assessing the risk of adverse cardiovascular events in patients with CAD and HF who have undergone CABG, based on preoperative GDF-15 concentrations. The study will include patients with a documented diagnosis of CHF and CAD who are recommended for coronary artery bypass grafting by the cardiac team. The study will collect and record patient examination and treatment data, which will be conducted in accordance with established standards of care for patients with CAD and will not be part of the study. The study will also analyze GDF-15. At each study center, upon patient enrollment, after signing informed consent, blood will be collected from the cubital vein in the morning before CABG. The blood will be collected in a vacuum tube containing 8 ml of clot activator (red-topped vacutainer) containing clot activator. Further preparation of the blood samples for analysis will include centrifugation for 10 minutes at 2,500 rpm, separation of the serum using a pipette into three 500 μg Eppendorf tubes, and freezing at -20°C. Serum samples will be transported by a specialized cold chain company. Analysis will be performed after a single thaw of the serum/plasma in the laboratory of the Cardiology Research Institute of Tomsk National Research Medical Center. The study will have a 12-month follow-up period; one in-person visit is planned at the end of the follow-up period. If it is not possible to visit a doctor in person, information will be collected through telephone contact with the patient or his relative or person caring for the patient.

Conditions

• Heart Failure
• CAD - Coronary Artery Disease
• CABG

Timeline

• Start date: 2026-03-04
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Russia