Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery

Evaluation of Post-operative, Nurse-based Heart Failure Care Compared to Standard Treatment in Patients With Heart Failure Undergoing Non-cardiac Surgery

Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)

Study Overview

• Status: Unknown
• Conditions: Heart Failure，Congestive
• Intervention / Treatment: Other: standard care; Other: Nurse-based care

• Study Type: Interventional
• Enrollment (Anticipated): 525
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birgit Assmus, MD; Phone Number: 5789 +49696301; Email: birgit.assmus@kgu.de
• Study Contact Backup: Name: Andreas M Zeiher, MD; Phone Number: 84690 +49696301; Email: zeiher@em.uni-frankfurt.de

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Klinikum Goethe University
    • Contact: Birgit Assmus, MD; Phone Number: 84690 +49 69 6301; Email: birgit.assmus@kgu.de
    • Contact: Andreas Ecke, MD; Phone Number: 84690 +49 69 6301; Email: andreas.ecke@kgu.de
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Enrolling by invitation
      • Goethe University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

patients with heart failure NYHA >= II (HFrEF and HFpEF) or LVEF <= 40% non-cardiac surgery planned later than 24 hours age > 18 years written informed consent

Exclusion Criteria:

patients on intensive care life-expectancy < 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: standard care; responsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively)	Other: standard care; cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon
Other: nurse-based care; heart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition	Other: Nurse-based care; board-certified heart failure nurses provide heart failure guidance post-operatively on every working day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite endpoint of in-hospital heart failure-related complications (readmission on ICU, re-initiation of inotropic support, pleural effusion, pulmonary edema, pneumonia requiring antibiotic treatment, non-invasive or invasive ventilation)	severe heart-failure related clinical events during hospitalisation for non-cardiac surgery	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
days in hospital	total days in hospital for non-cardiac surgery	90 days
acute kidney injury	Acute kidney injury grade: 0 = Creatinine increase < 1,5 x baseline, Stage 1 Creatinine increase > 1,5 x baseline, Stage 2 Creatinine increase > 2 x baseline, Stage 3 Creatinine increase > 3 x baseline)	90 days
Qulity of Life by SF-12	repetitive assessment with SF-12	90 days

Collaborators and Investigators

• Sponsor: Birgit Assmus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HFS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No