Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure
Recruiting · NCT06381427 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery.
Who can take part
Inclusion criteria
- Age ≥ 65 years
- Elective non-cardiac surgical operation with intermediate or high operative risk under general anesthesia or combined anesthesia (general and regional anesthesia) as per Figure 1
- ASA (American Society of Anesthesiologists) grade ≥ II
- Qualification for randomization: NT-proBNP ≥ 450pg/ml during routine preoperative evaluation and anesthesia consultation.
Exclusion criteria
- Age \< 65 years
- Cardiac surgery and cardiology interventional procedures
- Transplantation surgery (e.g., kidney, liver, lung transplantation)
- Kidney surgery (e.g., nephrectomy, partial nephrectomy)
- Procedures involving cardiopulmonary bypass
- Emergency surgery
- Surgery under general anesthesia within the last 30 days
- Primary use of local or regional anesthesia
- Chronic kidney insufficiency with eGFR \< 15 ml/min or dialysis-dependent kidney insufficiency
- Surgical time \< 30 minutes
- Participation in another interventional study
- Lack of consent
- Limited language proficiency
- Patient's limited or absent capacity to provide consent, as well as patients under legal guardianship
Where it is running
1 location listed.
- Justus Liebig University Giessen, University Hospital Giessen and Marburg - Giessen, Germany