Risk Stratification of MACE in Heart Failure Patients Who Undergoing CABG

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to the end of treatment at 12 months

Secondary outcomes

1

Deaths from cardiovascular causes (percentage)

Frequency of deaths from cardiovascular causes (percentage)

Time frame
From enrollment to the end of treatment at 12 months
2

All-cause mortality

All-cause mortality rate (percentage)

Time frame
From enrollment to the end of treatment at 12 months
3

HF hospitalization (percentage)

Frequency of cases of HF hospitalization (percentage)

Time frame
From enrollment to the end of treatment at 12 months
4

Acute ischemic events (percentage)

The incidence of acute ischemic events requiring unplanned revascularization (percentage)

Time frame
From enrollment to the end of treatment at 12 months

Other outcomes

Sponsors and contacts

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