Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

NCT06381427 | Recruiting

• 1 other identifier: 01NVF22109
• Study Type: interventional
• Target: 1,057
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of acute kidney injury

  at 30 and 90 days

• Incidence of any, treatable, suspected, or confirmed bacterial infection

  at 30 and 90 days

• Incidence of cardiac decompensation

  at 30 and 90 days

• Incidence of re-hospitalization

  at 30 and 90 days

• Mortality

  at 30 and 90 days

Other Outcomes (1)

• Utilization of services and costs

  during the intervention at the hospital

Study Arms (2)

Standard group

NO INTERVENTION

In this group, the anesthesiological risk evaluation is generally conducted in accordance with the current guidelines. Possible additional (instrumental) examinations, intraoperative anesthesiological management, and postoperative inpatient therapy are carried out according to current guidelines and are unaffected by study participation. If services are provided in the control group within the local standards that are also part of the new care model, these will be documented to ensure comparability.

Intervention group

ACTIVE COMPARATOR

A cardiology consultation is conducted, which includes a standardized evaluation. This includes, medical history and physical examination:ECG, Echocardiography, Determination of cardiac troponins and natriuretic peptides in the local central laboratory. The echocardiography aims to qualitatively and quantitatively describe the left and right ventricular systolic and diastolic dimensions and function, as well as the valvular apparatus, the collected findings are presented at the interdisciplinary and intersectoral preoperative medical (POM) conference. Bedside visits with the patient are also possible.During this conference, structured preoperative interdisciplinary and intersectoral case discussions take place, involving the attending outpatient physicians. The POM conference consists of Anesthesiology, Cardiologist, Treating surgeon and optimize preoperative therapy and plan further pre-, intra-, and postoperative as well as outpatient care.

Other: Interdisciplinary decision-making for perioperative care

Interventions

Interdisciplinary decision-making for perioperative care OTHER

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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead
• Deutsche Luft und Raumfahrt: collaborator

Study Sites (1)

Justus Liebig University Giessen, University Hospital Giessen and Marburg

Giessen, 35390, Germany

RECRUITING

Related Publications (1)

• PeriOP-CARE HF study group. Perioperative interdisciplinary optimisation of patients with heart failure undergoing non-cardiac surgery with intermediate or high surgical risk: the rationale and study protocol for the multicentre, randomised interventional PeriOP-CARE HF trial. Clin Res Cardiol. 2025 May;114(5):523-531. doi: 10.1007/s00392-025-02626-3. Epub 2025 Apr 29.

  PMID: 40299034 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Perioperative Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Götz Schmidt, MD

CONTACT

+4964198544401; goetz.f.schmidt@chiru.med.uni-giessen.de

Marit Habicher, MD

CONTACT

+4964198544401

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: April 24, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)