NCT06381427 Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure
| NCT ID | NCT06381427 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Giessen |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,057 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,057 participants in total. It began in 2024-09-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 language proficiency * Patient's limited or absent capacity to provide consent, as well as patients under legal guardianship
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06381427 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06381427 currently recruiting?
Yes, NCT06381427 is actively recruiting participants. Contact the research team at goetz.f.schmidt@chiru.med.uni-giessen.de for enrollment information.
Where is the NCT06381427 trial being conducted?
This trial is being conducted at Giessen, Germany.
Who is sponsoring the NCT06381427 clinical trial?
NCT06381427 is sponsored by University of Giessen. The trial plans to enroll 1,057 participants.
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