I50.1
Conditions
Interventions
Group 1: Prospective observational cohort of adult patients with heart failure with reduced left ventricular ejection fraction scheduled for isolated off-pump coronary artery bypass grafting at the Un
Sponsors
Universitätsklinikum der Eberhard-Karls-Universität Tübingen, Klinik für Thorax-, Herz- und Gefäßchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years or older with heart failure with reduced left ventricular ejection fraction, defined as a preoperative left ventricular ejection fraction =40%, scheduled for isolated coronary artery bypass grafting without primary use of cardiopulmonary bypass at the University Hospital Tübingen are eligible for inclusion. Additional inclusion criteria are: - planned isolated coronary artery bypass grafting on the beating heart, - ability to participate in the study and follow-up assessments, - written informed consent provided by the patient after study information.
Exclusion criteria
Exclusion criteria: Exclusion criteria are: - age below 18 years, - absence or withdrawal of written informed consent, - primarily planned coronary artery bypass grafting with cardiopulmonary bypass, - combined cardiac surgical procedures in addition to coronary artery bypass grafting, for example valve surgery or aortic surgery, - absence of heart failure with reduced left ventricular ejection fraction according to the study protocol, - inability to collect the baseline and follow-up data required for the study. Intraoperative conversion from an initially planned off-pump procedure to a procedure with cardiopulmonary bypass is documented as a perioperative event and does not automatically lead to exclusion from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is a prospective, non-interventional cohort study with several predefined perioperative and long-term outcome domains, no single primary endpoint in the sense of an interventional efficacy trial is defined. The primary aim of the study is the prospective and standardized characterization of the perioperative and postoperative clinical course of adult patients with heart failure with reduced left ventricular ejection fraction undergoing isolated off-pump coronary artery bypass grafting. For this purpose, preoperative risk factors, intraoperative treatment data, postoperative intensive care and ward trajectories, and clinical outcomes are assessed during the index hospital stay, at 30 days, and at 6, 12, and 24 months. Data are collected from routine clinical documentation, including operative reports, intensive care and ward records, laboratory and imaging findings, discharge summaries and follow-up contacts, and are documented in a standardized electronic case report form (REDCap eCRF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include in-hospital mortality, 30-day mortality, and mortality at 6, 12, and 24 months, major adverse cardiac and cerebrovascular events (MACCE), myocardial infarction, stroke, repeat revascularization, postoperative low cardiac output syndrome, intraoperative conversion to on-pump CABG, need for catecholamines or mechanical circulatory support, acute kidney injury according to KDIGO criteria, need for renal replacement therapy, blood loss, transfusion requirements, surgical revision for bleeding, duration of mechanical ventilation, prolonged ventilation, reintubation, tracheostomy, intensive care unit and hospital length of stay, delirium, neurological complications, infections, sepsis, wound complications, readmission, quality of life, and functional status during follow-up. Secondary outcomes are assessed perioperatively, during the index hospital stay, at the 30-day follow-up, and at 6, 12, and 24 months. Data are collected from routine clinical documentation, laboratory and imaging findings, intensive care and ward records, validated or standardized clinical scores, discharge summaries, and follow-up contacts, and are documented in the REDCap eCRF. | — |
Countries
Germany
Contacts
Public ContactChristian Rustenbach
Universtitätsklinikum der Eberhard-Karls-Universität Tübingen, Klinik für Thorax-, Herz- und Gefäßchirurgie
Outcome results
None listed