Predicting major heart problems after coronary artery bypass grafting in people with heart failure
Risk Stratification of MACE Based on GDF-15 in Heart Failure Patients Who Undergoing Coronary Artery Bypass Grafting: an Observational Multicenter Prospective Study
This study will test whether a blood marker called GDF-15 taken before bypass surgery can help predict major heart events over the year after CABG in patients with chronic heart failure and coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Sex | All |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences Academic / other |
| Locations | 1 site (Tomsk, Tomsk Oblast) |
| Trial ID | NCT07480915 on ClinicalTrials.gov |
What this trial studies
PROFILE-HF is a prospective, multicenter observational cohort of patients with chronic heart failure and coronary artery disease who are scheduled for coronary artery bypass grafting. At enrollment a preoperative blood sample will be taken and serum stored for measurement of GDF-15, with standardized processing and cold-chain transport to a central laboratory. Participants will be followed for 12 months for major adverse cardiovascular events (MACE) with one planned in-person visit at the end of follow-up or telephone contact if needed. Clinical care and treatments are managed according to standard practice and recorded but not altered by the study.
Who should consider this trial
Good fit: Adults with a documented diagnosis of chronic heart failure and coronary artery disease who are planned for isolated coronary artery bypass grafting and can provide informed consent and a preoperative blood sample are ideal candidates.
Not a fit: Patients with recent myocardial infarction or stroke, implanted cardiac devices, need for additional cardiac surgery, severe renal failure (GFR <30), active cancer, infiltrative or autoimmune cardiac disease, or acute infections were excluded and therefore are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the test could help identify patients at higher risk of major cardiac events after CABG so clinicians can target closer monitoring or tailored therapy.
How similar studies have performed: Biomarker approaches including GDF-15 have previously shown prognostic value in heart failure and coronary disease cohorts, but using preoperative GDF-15 specifically for CABG risk stratification has been less widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Heart Failure * Planned coronary artery bypass grafting Exclusion Criteria: * Myocardial infarction * Stroke * Presence of implanted devices; * Need for additional cardiac surgery other than coronary artery bypass grafting (valve repair, aneurysm); * Severe renal dysfunction (GFR \<30 ml/min/1.73 m2); * Severe comorbidities: active cancer; infiltrative cardiac diseases (sarcoidosis, amyloidosis, storage diseases); autoimmune diseases; acute infectious diseases and exacerbations of chronic somatic diseases.
Where this trial is running
Tomsk, Tomsk Oblast
- Cardiology Research Institute, Tomsk National Research Medical Center Russian Academy of Sciences — Tomsk, Tomsk Oblast, Russia (Recruiting)
Study contacts
- Principal investigator: Alla A. Garganeeva, MD, PhD — Tomsk NRMC
- Study coordinator: Alla A. Garganeeva, MD, PhD
- Email: aag@cardio-tomsk.ru
- Phone: +7 (3822) 56 52 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.