NCT07480915

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 4, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 12, 2026

Last Update Submit

March 13, 2026

Conditions

Heart FailureCAD - Coronary Artery DiseaseCABG

Keywords

Heart FailureCoronary Artery DiseaseCABGCoronary Artery Bypass GraftingGDF-15Growth differentiation factor - 15Prognosis

Outcome Measures

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).

    From enrollment to the end of treatment at 12 months

Secondary Outcomes (5)

  • Deaths from cardiovascular causes (percentage)

    From enrollment to the end of treatment at 12 months

  • All-cause mortality

    From enrollment to the end of treatment at 12 months

  • HF hospitalization (percentage)

    From enrollment to the end of treatment at 12 months

  • Acute ischemic events (percentage)

    From enrollment to the end of treatment at 12 months

  • Secondary composite endpoint (percentage)

    From enrollment to the end of treatment at 12 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Heart Failure
  • Planned coronary artery bypass grafting

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Research Institute, Tomsk National Research Medical Center Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634050, Russia

RECRUITING

MeSH Terms

Conditions

Heart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Alla A. Garganeeva, MD, PhD

    Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alla A. Garganeeva, MD, PhD

CONTACT

+7 (3822) 56 52 75aag@cardio-tomsk.ru

Elena A. Kuzheleva, MD, PhD

CONTACT

+7 (3822) 56 52 75kea@cardio-tomsk.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 18, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)