Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06381427

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

Led by University of Giessen · Updated on 2025-03-03

1057

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

U

University of Giessen

Lead Sponsor

D

Deutsche Luft und Raumfahrt

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Scheduled for elective non-cardiac surgery with intermediate or high operative risk under general or combined anesthesia
  • ASA grade II or higher
  • NT-proBNP level 450 pg/ml or higher during routine preoperative evaluation and anesthesia consultation
Not Eligible

You will not qualify if you...

  • Age below 65 years
  • Cardiac surgery or cardiology interventional procedures
  • Transplantation surgery such as kidney, liver, or lung transplant
  • Kidney surgery including nephrectomy or 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 less than 15 ml/min or dialysis dependence
  • Surgery lasting less than 30 minutes
  • Participation in another interventional study
  • Lack of consent
  • Limited language skills
  • Limited or absent capacity to provide consent or patients under legal guardianship

AI-Screening

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Trial Site Locations

Total: 1 location

1

Justus Liebig University Giessen, University Hospital Giessen and Marburg

Giessen, Germany, 35390

Actively Recruiting

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Research Team

G

Götz Schmidt, MD

CONTACT

M

Marit Habicher, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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