About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Heart Failure
Planned coronary artery bypass grafting
Disqualifiers
Myocardial infarction
Stroke
Presence of implanted devices;
Need for additional cardiac surgery other than coronary artery bypass grafting (valve repair, aneurysm);
Trial population
At each study center, patients with CHF and ischemic heart disease will be assessed for inclusion and exclusion criteria when deciding on the need for CABG and whether the patient consents to the procedure. The principal investigator is expected to ensure that all patients meeting the inclusion and exclusion criteria are consistently enrolled in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Time to first adverse cardiovascular event (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 outcomes
Deaths from cardiovascular causes (percentage)
Frequency of deaths from cardiovascular causes (percentage)
All-cause mortality
All-cause mortality rate (percentage)
HF hospitalization (percentage)
Frequency of cases of HF hospitalization (percentage)
Acute ischemic events (percentage)
The incidence of acute ischemic events requiring unplanned revascularization (percentage)
Sponsors and contacts
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