Clinical trial Recruiting at 1 site Observational

Predicting major heart problems after coronary artery bypass grafting in people with heart failure

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

Run by Tomsk National Research Medical Center of the Russian Academy of Sciences · NCT07480915 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment160 (estimated)
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
Academic / other
Locations1 site (Tomsk, Tomsk Oblast)
StatusRecruiting
StartedMarch 4, 2026
Main results expectedMarch 2027
Study endsMarch 2028
Registry record updatedOctober 6, 2026
Trial IDNCT07480915 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Cardiology Research Institute, Tomsk National Research Medical Center Russian Academy of Sciences
    Tomsk, Tomsk Oblast, Russia
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.