Ischemic Cardiomyopathy
Conditions
Keywords
Heart Failure, Ventricular Dysfunction, Ischemic Cardiomyopathy, Ischemic Heart Disease, Revascularization, Percutaneous Coronary Intervention, Randomized Control Trial, Implantable Cardioverter Defibrillator
Brief summary
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.
Interventions
PROCEDUREPercutaneous Coronary Intervention
DRUGDrug Therapy for Heart Failure
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
DEVICEDevice Therapy for Heart Failure
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.
Sponsors
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
University of York
Guy's and St Thomas' NHS Foundation Trust
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ALL of the following: 1. Poor left ventricular function (EF≤35%) 2. Extensive coronary disease 3. Viability in at least 4 dysfunctional segments that can be revascularised by PCI
Exclusion criteria
1. Myocardial infarction \< 4 weeks prior to randomisation (clinical definition) 2. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Balloon Pump/left ventricular assist device therapy \<72 hours prior to randomization 3. Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges \<72 hours prior to randomization 4. Valve disease requiring intervention 5. Contraindications to percutaneous coronary intervention 6. Age \<18 yrs 7. Estimated Glomerular Filtration Rate \< 25 ml/min, unless established on dialysis 8. Women who are pregnant 9. Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data 10. Life expectancy \< 1 yr due to non-cardiac pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death or Hospitalization for Heart Failure | 1 to 103 months (min follow-up duration: 24 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction | 6 months, 1 year | Left Ventricular Ejection Fraction (LVEF) on echocardiography |
| Quality of Life Scores | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years | 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. |
| New York Heart Association Functional (NYHA) Class | 6 months, 1 year, 2 years | — |
| Cardiovascular Death | 1 to 103 months (min follow-up duration: 24 months) | Cardiovascular death over the entire duration of follow-up |
| All-cause death | 1 to 103 months (min follow-up duration: 24 months) | All-cause death over the entire duration of follow-up |
| Hospitalization due to heart failure | 1 to 103 months (min follow-up duration: 24 months) | Hospitalization due to heart failure over the entire duration of follow-up |
| Appropriate Implantable Cardioverter Defibrillator Therapy | 6 months, 1 year, 2 years | Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years |
| Unplanned further revascularization | 1 to 103 months (min follow-up duration: 24 months) | Unplanned further revascularization over the entire duration of follow-up |
| Canadian Cardiovascular Society class | 6 months, 1 year, 2 years | Canadian Cardiovascular Society (CCS) class up to 2 years |
| Brain-type Natriuretic Peptide level | 6 months, 1 year, 2 years | Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years |
| Major Bleeding | 6 months, 1 year, 2 years | Major bleeding up to 2 years |
| Acute Myocardial Infarction | 1 to 103 months (min follow-up duration: 24 months) | Acute myocardial infarction (MI) over the entire duration of follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| NHS Resource Use | 1 to 103 months (min follow-up duration: 24 months) | Health Economic Analysis |
Countries
United Kingdom
Outcome results
None listed