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

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ClinicalTrials.gov Identifier: NCT03202329
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Birgit Assmus, PD Dr., Johann Wolfgang Goethe University Hospital

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Heart FailureCongestive Other: standard care Other: Nurse-based care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Post-operative, Nurse-based Heart Failure Care Compared to Standard Treatment in Patients With Heart Failure Undergoing Non-cardiac Surgery
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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) [ Time Frame: 30 days ]
    severe heart-failure related clinical events during hospitalisation for non-cardiac surgery


Secondary Outcome Measures :
  1. days in hospital [ Time Frame: 90 days ]
    total days in hospital for non-cardiac surgery

  2. acute kidney injury [ Time Frame: 90 days ]
    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)

  3. Qulity of Life by SF-12 [ Time Frame: 90 days ]
    repetitive assessment with SF-12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202329


Contacts
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Contact: Birgit Assmus, MD +49696301 ext 5789 birgit.assmus@kgu.de
Contact: Andreas M Zeiher, MD +49696301 ext 84690 zeiher@em.uni-frankfurt.de

Locations
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Germany
Goethe University Hospital Enrolling by invitation
Frankfurt, Hessen, Germany, 60590
Klinikum Goethe University Recruiting
Frankfurt am Main, Germany, 60590
Contact: Birgit Assmus, MD    +49 69 6301 ext 84690    birgit.assmus@kgu.de   
Contact: Andreas Ecke, MD    +49 69 6301 ext 84690    andreas.ecke@kgu.de   
Sponsors and Collaborators
Birgit Assmus, PD Dr.

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Responsible Party: Birgit Assmus, PD Dr., Prof. Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03202329     History of Changes
Other Study ID Numbers: HFS-01
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases