NCT06381427Recruiting
Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure
Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure: A Multicenter, Prospective-randomized Intervention Study
Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1057 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- University of Giessen
- Diseases
- Heart failure
- NCT number
- NCT06381427
What you commit to
- Study type: Interventional
- Planned participants: 1057
- From 1 Sept 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Transplantation surgery (e.g., kidney, liver, lung transplantation)
- Kidney surgery (e.g., nephrectomy, partial nephrectomy)
- Emergency surgery
- Surgery under general anesthesia within the last 30 days
- Surgical time \< 30 minutes
Other illness
- Cardiac surgery and cardiology interventional procedures
Lab values
- Chronic kidney insufficiency with eGFR \< 15 ml/min or dialysis-dependent kidney insufficiency
Age
- Age \< 65 years
Other
- Procedures involving cardiopulmonary bypass
- Primary use of local or regional anesthesia
- 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
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Justus Liebig University Giessen, University Hospital Giessen and Marburg Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.