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

Heart Failure,Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03202329
• Other study ID #: HFS-01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

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