Clinical trial NCT06381427: Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure
Official title: Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure: A Multicenter, Prospective-randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Deutsche Luft und Raumfahrt
First posted: 2024-04-24
Enrollment: 1057
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Currently, up to three million people in Germany suffer from chronic heart failure, with prevalence increasing with age. Chronic heart failure ranks among the most common cardiovascular diseases, leading to over 50,000 deaths annually. The proportion of older patients at risk of developing or already having heart failure undergoing non-cardiac surgical procedures is also rising. Studies from the USA indicate that patients with chronic heart failure face a higher risk of cardiac complications, including death, following non-cardiac surgeries compared to those with coronary heart disease. A significant proportion of deaths after non-cardiac surgeries are due to cardiac complications. In Europe, this translates to at least 167,000 cardiac complications annually from non-cardiac surgeries, with around 19,000 being life-threatening. Recent analysis suggests that preoperative elevation of NT-proBNP, a heart failure biomarker, is associated with a significantly increased risk of cardiac complications post-surgery. While German data on this topic are lacking, anesthesia and cardiology guidelines advocate for comprehensive evaluation and risk assessment of heart failure patients before non-cardiac surgeries with medium to high operative risk. However, there's a lack of systematic structures for assessing postoperative morbidity and mortality risks in an interdisciplinary and intersectoral context. Due to workload and resource constraints, comprehensive risk assessments are often delayed until shortly before surgery, leading to inadequate peri- and postoperative care. Evidence supporting improved outcomes through preoperative optimization of heart failure patients and risk-adapted precision medicine for non-cardiac surgeries is also lacking. Consequently, this study aims to evaluate a care model providing multimodal, interdisciplinary, and intersectoral optimization for high-risk patients aged 65 and above with elevated heart failure biomarkers (NT-proBNP\>450), regardless of prior heart failure diagnosis. The null hypothesis posits that standardized risk screening and multidimensional interdisciplinary care cannot reduce postoperative complications in these high-risk patients undergoing non-cardiac surgeries.

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

Primary outcomes:
measure: combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation
timeFrame: 90 days post-operation
Secondary outcomes:
measure: Incidence of acute kidney injury
timeFrame: at 30 and 90 days
measure: Incidence of any, treatable, suspected, or confirmed bacterial infection
timeFrame: at 30 and 90 days
measure: Incidence of cardiac decompensation
timeFrame: at 30 and 90 days
measure: Incidence of re-hospitalization
timeFrame: at 30 and 90 days
measure: Mortality
timeFrame: at 30 and 90 days
measure: Incidence of myocardial infarction (STEMI, NSTEMI)
timeFrame: at 30 and 90 days
measure: Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS)
timeFrame: at 30 and 90 days
measure: Quality of life assessed using PHQ-9
timeFrame: at 30 and 90 days
measure: Quality of life assessed using GAD-7
timeFrame: at 30 and 90 days
Other outcomes:
measure: Utilization of services and costs
timeFrame: during the intervention at the hospital
Locations:
city: Gießen
country: Germany
facility: Justus Liebig University Giessen, University Hospital Giessen and Marburg
Study officials:
References: