Risk Stratification of MACE in Heart Failure Patients Who Undergoing CABG (PROFILE-HF)

March 13, 2026 updated by: Elena A. Kuzheleva, Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alla A. Garganeeva, MD, PhD
  • Phone Number: +7 (3822) 56 52 75
  • Email: aag@cardio-tomsk.ru

Study Contact Backup

  • Name: Elena A. Kuzheleva, MD, PhD
  • Phone Number: +7 (3822) 56 52 75
  • Email: kea@cardio-tomsk.ru

Study Locations

  • Russia
    • Tomsk Oblast
      • Tomsk, Tomsk Oblast, Russia, 634050
        • Recruiting
        • Cardiology Research Institute, Tomsk National Research Medical Center Russian Academy of Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first adverse cardiovascular event (months)
Time Frame: 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).
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deaths from cardiovascular causes (percentage)
Time Frame: From enrollment to the end of treatment at 12 months
Frequency of deaths from cardiovascular causes (percentage)
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
All-cause mortality rate (percentage)
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
Frequency of cases of HF hospitalization (percentage)
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
The incidence of acute ischemic events requiring unplanned revascularization (percentage)
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
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).
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Alla A. Garganeeva, MD, PhD, Tomsk NRMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • №293_04.03.2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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