heart failure
Conditions
Interventions
None.
Sponsors
Center for Translational Molecular Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Patients to be included must meet the following criteria: 1. Men and women, aged 18 years or older, capable of understanding and signing informed consent; 2. Hospital admission with a diagnosis of acute heart failure (i.e. new presentation of heart failure or exacerbation of known, chronic heart failure); 3. Natriuretic peptide (BNP or NT-proBNP) levels ¡Ý 3 x ULN; 4. Treated with intravenous diuretics during the hospitalization; 5. All patients have to provide written informed consent; 6. Evidence of sustained systolic or diastolic left ventricular dysfunction on echocardiography (recorded within the last year or during current hospitalization).
Exclusion criteria
Exclusion criteria: Patients will be excluded from this study for any of the following reasons: 1. Heart failure precipitated by a non-cardiac condition (e.g. severe anemia, pulmonary embolism, thyrotoxicosis, etc); 2. The clinical syndrome of heart failure caused by severe valvular dysfunction or severe cardiac arrhythmias without evidence of sustained systolic or diastolic dysfunction; 3. Acute heart failure caused by an acute ST-segment elevation myocardial infarction requiring reperfusion therapy; 4. Acute heart failure caused by an acute coronary syndrome without evidence of sustained systolic or diastolic dysfunction; 5. A planned coronary intervention (PCI and/or CABG); 6. Patients with end-stage heart failure who are on the waiting list for cardiac transplantation; 7. End-stage chronic kidney disease requiring dialysis; 8. Non-cardiac condition associated with a life-expectancy <1 year, or otherwise unlikely to appear at all scheduled follow-up visits;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the composite of cardiovascular death, left ventricular assist device implantation, heart transplantation or re-hospitalization for the management of acute heart failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include: 1. Individual components of the primary endpoint, i.e. cardiovascular death, left ventricular assist device implantation, heart transplantation and re-hospitalization for acute heart failure; 2. Cardiovascular death, left ventricular assist device implantation, heart transplantation, re-admission to hospital for acute heart failure, or non-fatal myocardial infarction; 3. Cardiovascular death, left ventricular assist device implantation, heart transplantation, re-admission to hospital for acute heart failure, non-fatal myocardial infarction, or non-fatal stroke. 4. Cardiovascular death, left ventricular assist device implantation, heart transplantation, re-admission to hospital for acute heart failure, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. 5. Death (any cause) or left ventricular assist device implantation, heart transplantation, re-admission to hospital for acute heart failure; 6. Number of appropriate ICD shocks; 7. Estimated glomerular filtration rate as measured with the simplified MDRD formula; 8. Quality of life by Kansas City Cardiomyopthy Questionnaire, EQ-5D; 9. Depressive symptoms by Hospital Anxiety and Depression scal; 10. Symptoms by symptom occurence and burden questionnaire. | — |
Contacts
Public ContactIvonne Lesman
PO Box 30.001
Outcome results
None listed