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NCT Number: NCT06381427

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Justus Liebig University Giessen, University Hospital Giessen and Marburg

Giessen, 35390, Germany

Location status: Recruiting

Location contact

Birgit Aßmus, PHD

CONTACT

Michael Sander, PhD

CONTACT

+4964198544401

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation

    Time frame: 90 days post-operation

    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.

Secondary outcomes

  1. Incidence of acute kidney injury

    Time frame: at 30 and 90 days

    Indicidence of acute kidney injury based on KDIGO classification, Stage 1,2,3

  2. Incidence of any, treatable, suspected, or confirmed bacterial infection

    Time frame: at 30 and 90 days

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

  3. Incidence of cardiac decompensation

    Time frame: at 30 and 90 days

    Incidence of cardiacx decompensation including lung edema, peropheral edema, dyspnoe, pleural effusion

  4. Incidence of re-hospitalization

    Time frame: at 30 and 90 days

    Incidence of re-hospitalization

  5. Mortality

    Time frame: at 30 and 90 days

    Mortality

  6. Incidence of myocardial infarction (STEMI, NSTEMI)

    Time frame: at 30 and 90 days

    Incidence of myocardial infarction (STEMI, NSTEMI)

  7. Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS)

    Time frame: at 30 and 90 days

    Incidence of Myocardial Injury after Non-Cardiac Surgery defined as an elevated troponin level

  8. Quality of life assessed using PHQ-9

    Time frame: at 30 and 90 days

    Quality of life assessed using Patient Health Questionnaire 9 (PHQ-9), score between 0 and 27, best score is 0

  9. Quality of life assessed using GAD-7

    Time frame: at 30 and 90 days

    Quality of life assessed using Generalized Anxiety Disorder Scale-7 (GAD-7), score between 0 and 21, best score is 0

Other outcomes

  1. Utilization of services and costs

    Time frame: during the intervention at the hospital

    Utilization of services and costs of each patient during the hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Götz Schmidt, MD

CONTACT

[email protected]

+4964198544401

Marit Habicher, MD

CONTACT

+4964198544401

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Deutsche Luft und Raumfahrt

Registry information

Official study title

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

Acronym: PeriOP-CARE HF

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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