Risk Stratification of MACE in Heart Failure Patients Who Undergoing CABG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, CAD - Coronary Artery Disease, CABG. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Time to first adverse cardiovascular event (months) [Time frame: From enrollment to the end of treatment at 12 months]
Secondary outcome measures (5)
- Deaths from cardiovascular causes (percentage) [Time frame: From enrollment to the end of treatment at 12 months]
- All-cause mortality [Time frame: From enrollment to the end of treatment at 12 months]
- HF hospitalization (percentage) [Time frame: From enrollment to the end of treatment at 12 months]
- Acute ischemic events (percentage) [Time frame: From enrollment to the end of treatment at 12 months]
- Secondary composite endpoint (percentage) [Time frame: From enrollment to the end of treatment at 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Cardiology Research Institute, Tomsk National Research Medical Center Russian Academy of S — Tomsk
Identifiers
NCT: NCT07480915 · №293_04.03.2026