Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

Heart Failure Clinical Trial

— PeriOP-CARE HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381427
• Other study ID #: 01NVF22109
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2024
• Source: University of Giessen
• Contact: Götz Schmidt, MD
• Phone: +4964198544401
• Email: goetz.f.schmidt[@]chiru.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1057
• Est. completion date: March 1, 2027
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Interdisciplinary 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.

Locations

Country	Name	City	State
Germany	Justus Liebig University Giessen, University Hospital Giessen and Marburg	Gießen

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	Deutsche Luft und Raumfahrt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utilization of services and costs	Utilization of services and costs of each patient during the hospital stay	during the intervention at the hospital
Primary	combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation	The combined primary endpoint at 90 days post-operation consists of re-hospitalization for any reason, acute kidney injury according to KDIGO definition, any bacterial infection, and cardiac decompensation.	90 days post-operation
Secondary	Incidence of acute kidney injury	Indicidence of acute kidney injury based on KDIGO classification, Stage 1,2,3	at 30 and 90 days
Secondary	Incidence of any, treatable, suspected, or confirmed bacterial infection	Incidence of any, treatable, suspected, or confirmed bacterial infection	at 30 and 90 days
Secondary	Incidence of cardiac decompensation	Incidence of cardiacx decompensation including lung edema, peropheral edema, dyspnoe, pleural effusion	at 30 and 90 days
Secondary	Incidence of re-hospitalization	Incidence of re-hospitalization	at 30 and 90 days
Secondary	Mortality	Mortality	at 30 and 90 days
Secondary	Incidence of myocardial infarction (STEMI, NSTEMI)	Incidence of myocardial infarction (STEMI, NSTEMI)	at 30 and 90 days
Secondary	Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS)	Incidence of Myocardial Injury after Non-Cardiac Surgery defined as an elevated troponin level	at 30 and 90 days
Secondary	Quality of life assessed using PHQ-9	Quality of life assessed using Patient Health Questionnaire 9 (PHQ-9), score between 0 and 27, best score is 0	at 30 and 90 days
Secondary	Quality of life assessed using GAD-7	Quality of life assessed using Generalized Anxiety Disorder Scale-7 (GAD-7), score between 0 and 21, best score is 0	at 30 and 90 days