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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03202329
Other study ID # HFS-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date June 1, 2021

Study information

Verified date July 2020
Source Johann Wolfgang Goethe University Hospital
Contact Birgit Assmus, MD
Phone +49696301
Email birgit.assmus@kgu.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 525
Est. completion date June 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
standard care
cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon
Nurse-based care
board-certified heart failure nurses provide heart failure guidance post-operatively on every working day

Locations

Country Name City State
Germany Goethe University Hospital Frankfurt Hessen
Germany Klinikum Goethe University Frankfurt am Main

Sponsors (1)

Lead Sponsor Collaborator
Birgit Assmus

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 days in hospital total days in hospital for non-cardiac surgery 90 days
Secondary 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
Secondary Qulity of Life by SF-12 repetitive assessment with SF-12 90 days
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