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Recruiting NCT06381427

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

Trial Parameters

Condition Heart Failure
Sponsor University of Giessen
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,057
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2024-09-01
Completion 2026-08-31
Interventions
Interdisciplinary decision-making for perioperative care

Brief Summary

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.

Eligibility Criteria

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 la

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