Heart Failure，Congestive
Conditions
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)
Interventions
OTHERstandard care
cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon
OTHERNurse-based care
board-certified heart failure nurses provide heart failure guidance post-operatively on every working day
Sponsors
Birgit Assmus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 30 days | severe heart-failure related clinical events during hospitalisation for non-cardiac surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| days in hospital | 90 days | total days in hospital for non-cardiac surgery |
| acute kidney injury | 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) |
| Qulity of Life by SF-12 | 90 days | repetitive assessment with SF-12 |
Countries
Germany
Contacts
Primary ContactBirgit Assmus, MD
Backup ContactAndreas M Zeiher, MD
Outcome results
None listed