Heart failure Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Onset of symptoms ± signs of heart failure in the past 12 months AND 2.1. Non-elective heart failure hospitalisation (where heart failure was the primary reason for hospitalisation in the opinion of the investigator) OR 2.2. Outpatients with LVEF =40% OR 2.3. Outpatients with LVEF >40% and NT-proBNP >300ng/L (sinus rhythm) or >600ng/L (AF)
Exclusion criteria
Exclusion criteria: 1. Previous investigations for coronary artery disease (CAD), where CAD was identified as the cause of heart failure 2. Clear alternative cause of heart failure (e.g. cardiac amyloidosis or hypertrophic cardiomyopathy) 3. Severe valvular heart disease thought to be the main cause of heart failure 4. Comorbid conditions with lifespan of less than a year (in the opinion of the investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first major adverse cardiovascular event (MACE) measured from randomisation for a minimum of 12 months: MACE defined as any of: 1. All cause death 2. Myocardial Infarction (MI) 3. Heart Failure Hospitalisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Total MACE events (MACE is defined as all-cause mortality, MI and heart failure hospitalisations) 2. Total (first and recurrent) HF hospitalisations 3. KCCQ-CSS at 6 and 12 months 4. Total Cardiovascular (CV) deaths 5. Total all-cause mortality | — |
Countries
England, Scotland, United Kingdom, Wales