RecruitingNot ApplicableNCT06381427

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure: A Multicenter, Prospective-randomized Intervention Study

Sponsor

University of Giessen

Enrollment

1,057 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Min Age: 65 Years

Inclusion Criteria4

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 Criteria14

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

Interventions

OTHERInterdisciplinary 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.