CABG, CAD - Coronary Artery Disease, Heart Failure
Conditions
Keywords
Heart Failure, Coronary Artery Disease, CABG, Coronary Artery Bypass Grafting, GDF-15, Growth differentiation factor - 15, Prognosis
Brief 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.
Interventions
None listed
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first adverse cardiovascular event (months) | From enrollment to the end of treatment at 12 months | Time to first adverse cardiovascular event, including cardiovascular (CV) death or nonfatal myocardial infarction (MI) and/or nonfatal stroke and/or unplanned revascularization and/or heart failure (HF) hospitalization and/or worsening of heart failure (worsening by at least one NYHA class requiring increased intensity of diuretic therapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deaths from cardiovascular causes (percentage) | From enrollment to the end of treatment at 12 months | Frequency of deaths from cardiovascular causes (percentage) |
| All-cause mortality | From enrollment to the end of treatment at 12 months | All-cause mortality rate (percentage) |
| HF hospitalization (percentage) | From enrollment to the end of treatment at 12 months | Frequency of cases of HF hospitalization (percentage) |
| Acute ischemic events (percentage) | From enrollment to the end of treatment at 12 months | The incidence of acute ischemic events requiring unplanned revascularization (percentage) |
| Secondary composite endpoint (percentage) | From enrollment to the end of treatment at 12 months | The incidence of a secondary composite endpoint including cardiovascular (CV) death or nonfatal myocardial infarction (MI) and/or nonfatal stroke and/or unplanned revascularization and/or and HF hospitalization (percentage). |
Countries
Russia
Contacts
CONTACTAlla A. Garganeeva, MD, PhD
CONTACTElena A. Kuzheleva, MD, PhD
PRINCIPAL_INVESTIGATORAlla A. Garganeeva, MD, PhD
Tomsk NRMC
Outcome results
None listed