Heart FailurePROFILE-HFNCT07480915
Risk Stratification of MACE in Heart Failure Patients Who Undergoing CABG
An observational study of Heart Failure and CAD - Coronary Artery Disease, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, CAD - Coronary Artery Disease, CABG
- How many people
- 160 participants
- Where
- 1 siteRussia
- Study dates
- 4 Mar 2026to Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Heart Failure
- Planned coronary artery bypass grafting
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Cardiology Research Institute, Tomsk National Research Medical Center Russian Academy of Sciences
Tomsk, Tomsk Oblast, 634050
Елена Кужелева, PhD, +7 (3822) 565275, kea@cardio-tomsk.ru
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, CAD - Coronary Artery Disease, CABG
- Keywords
- Heart Failure, Coronary Artery Disease, CABG, Coronary Artery Bypass Grafting, GDF-15, Growth differentiation factor - 15, Prognosis
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (5)
Deaths from cardiovascular causes (percentage)
Frequency of deaths from cardiovascular causes (percentage)
Measured: From enrollment to the end of treatment at 12 months
All-cause mortality
All-cause mortality rate (percentage)
Measured: From enrollment to the end of treatment at 12 months
HF hospitalization (percentage)
Frequency of cases of HF hospitalization (percentage)
Measured: From enrollment to the end of treatment at 12 months
Acute ischemic events (percentage)
The incidence of acute ischemic events requiring unplanned revascularization (percentage)
Measured: From enrollment to the end of treatment at 12 months
Secondary composite endpoint (percentage)
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).
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start4 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena A. Kuzheleva, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Alla A. Garganeeva, MD, PhD, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480915
- Sponsor's protocol ID
- CRI-293
- Acronym
- PROFILE-HF
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No