Status:
COMPLETED
Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure
Lead Sponsor:
King's College London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
Conditions:
Ischemic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 dis...
Eligibility Criteria
Inclusion
- ALL of the following:
- Poor left ventricular function (EF≤35%)
- Extensive coronary disease
- Viability in at least 4 dysfunctional segments that can be revascularised by PCI
Exclusion
- Myocardial infarction \< 4 weeks prior to randomisation (clinical definition)
- 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
- Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges \<72 hours prior to randomization
- Valve disease requiring intervention
- Contraindications to percutaneous coronary intervention
- Age \<18 yrs
- Estimated Glomerular Filtration Rate \< 25 ml/min, unless established on dialysis
- Women who are pregnant
- Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
- Life expectancy \< 1 yr due to non-cardiac pathology
Key Trial Info
Start Date :
August 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01920048
Start Date
August 28 2013
End Date
March 31 2022
Last Update
May 31 2022
Active Locations (40)
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1
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA
2
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
3
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
4
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR