This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines
The optimal device therapy for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines. In most cases the device will be an Implantable Cardioverter Defibrillator and/or Cardiac Resynchronization Therapy.
All-cause death or Hospitalization for Heart Failure
This composite endpoint will be collected over the entire duration of follow-up in the trial when the last patient randomized has reached 2 years of follow-up post randomization
Time frame: 1 to 103 months (min follow-up duration: 24 months)
Left Ventricular Ejection Fraction
Left Ventricular Ejection Fraction (LVEF) on echocardiography
Time frame: 6 months, 1 year
Quality of Life Scores
Kansas City Cardiomyopathy questionnaire (KCCQ) up to 2 years EuroQol EQ-5D-5L at 6 months and then yearly to the end of follow-up.
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
New York Heart Association Functional (NYHA) Class
Time frame: 6 months, 1 year, 2 years
Cardiovascular Death
Cardiovascular death over the entire duration of follow-up
Time frame: 1 to 103 months (min follow-up duration: 24 months)
All-cause death
All-cause death over the entire duration of follow-up
Time frame: 1 to 103 months (min follow-up duration: 24 months)
Hospitalization due to heart failure
Hospitalization due to heart failure over the entire duration of follow-up
Time frame: 1 to 103 months (min follow-up duration: 24 months)
Acute Myocardial Infarction
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Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
North Wales Cardiac Centre
Bodelwyddan, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Bristol Heart Institute
Bristol, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Dorset County Hospital
Dorchester, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
...and 30 more locations
Acute myocardial infarction (MI) over the entire duration of follow-up
Time frame: 1 to 103 months (min follow-up duration: 24 months)
Appropriate Implantable Cardioverter Defibrillator Therapy
Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years
Time frame: 6 months, 1 year, 2 years
Unplanned further revascularization
Unplanned further revascularization over the entire duration of follow-up
Time frame: 1 to 103 months (min follow-up duration: 24 months)
Canadian Cardiovascular Society class
Canadian Cardiovascular Society (CCS) class up to 2 years
Time frame: 6 months, 1 year, 2 years
Brain-type Natriuretic Peptide level
Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years
Time frame: 6 months, 1 year, 2 years
Major Bleeding
Major bleeding up to 2 years
Time frame: 6 months, 1 year, 2 years