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Clinical Trials in Germany / NCT06381427
Recruiting Not applicable

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

NCT06381427 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-09-01
Last updated
2025-03-03

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Interdisciplinary decision-making for perioperative care

Interdisciplinary decision-making for perioperative care: Interdisciplinary decision-making for perioperative care involving a cardiologist, anesthesiologist, and surgeon in collaboration with the primary care physician. Decisions include determining whether surgery is feasible or if patient optimization is necessary first. Subsequently, targeted postoperative visits by a heart failure nurse and appropriate postoperative care, also after discharge from the hospital, through the primary care physician.

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Justus Liebig University Giessen, University Hospital Giessen and Marburg Giessen Germany Recruiting

More University of Giessen trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06381427 on ClinicalTrials.gov ↗ ← All trials in Germany