Improving perioperative care for heart failure patients
Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure: A Multicenter, Prospective-randomized Intervention Study
NA · University of Giessen · NCT06381427
This study is testing a new way to improve care for older heart failure patients during and after non-heart surgery to see if it helps them avoid complications and recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1057 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Giessen (other) |
| Locations | 1 site (Giessen) |
| Trial ID | NCT06381427 on ClinicalTrials.gov |
What this trial studies
This study evaluates a multidisciplinary approach to optimize perioperative care for high-risk patients aged 65 and older undergoing non-cardiac surgery. It focuses on patients with elevated NT-proBNP levels, randomizing them into standard care or an intervention group that receives enhanced risk screening and multidimensional care. The goal is to reduce postoperative complications and improve outcomes for these patients, who are at a higher risk of cardiac issues during surgery. The study addresses the lack of systematic risk assessment structures in current clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 65 and older with elevated NT-proBNP levels who are scheduled for elective non-cardiac surgeries with intermediate or high operative risk.
Not a fit: Patients under 65 years old, those undergoing cardiac surgeries, or those with severe kidney insufficiency are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve survival rates for older patients with heart failure undergoing surgery.
How similar studies have performed: While there is limited data from Germany, studies in other regions have indicated that comprehensive preoperative evaluations can improve outcomes for heart failure patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Giessen
- Justus Liebig University Giessen, University Hospital Giessen and Marburg — Giessen, Germany (RECRUITING)
Study contacts
- Study coordinator: Götz Schmidt, MD
- Email: goetz.f.schmidt@chiru.med.uni-giessen.de
- Phone: +4964198544401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure