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

Study Overview
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Brief Summary
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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)

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

Conditions
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Heart Failure，Congestive

Intervention / Treatment
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* Other: standard care
* Other: Nurse-based care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: standard care<br>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<br>* cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon<br>|
| Other: nurse-based care<br>heart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition | Other: Nurse-based care<br>* board-certified heart failure nurses provide heart failure guidance post-operatively on every working day<br>|

What is the study measuring?
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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 |