Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure

Not Applicable

Completed

• Conditions: Ischemic Cardiomyopathy
• Interventions: Procedure: Percutaneous Coronary Intervention; Drug: Drug Therapy for Heart Failure; Device: Device Therapy for Heart Failure

• Registration Number: NCT01920048
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-09
• Study Start: 2013-08-28
• Primary Completion: 2020-03-19
• Study Completion: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Coronary Intervention and Optimal Medical Therapy	Drug Therapy for Heart Failure	-
Optimal Medical Therapy alone	Device Therapy for Heart Failure	-
Percutaneous Coronary Intervention and Optimal Medical Therapy	Percutaneous Coronary Intervention	-
Percutaneous Coronary Intervention and Optimal Medical Therapy	Device Therapy for Heart Failure	-
Optimal Medical Therapy alone	Drug Therapy for Heart Failure	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
Left Ventricular Ejection Fraction	6 months, 1 year	Left Ventricular Ejection Fraction (LVEF) on echocardiography
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
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
New York Heart Association Functional (NYHA) Class	6 months, 1 year, 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

Trial Locations

Locations (40)

University Hospital Coventry; 🇬🇧 Coventry, United Kingdom

Great Western Hospital; 🇬🇧 Swindon, United Kingdom

Basingstoke and North Hampshire Hospital; 🇬🇧 Basingstoke, United Kingdom

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, United Kingdom

North Wales Cardiac Centre; 🇬🇧 Bodelwyddan, United Kingdom

Bristol Heart Institute; 🇬🇧 Bristol, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Glenfield Hospital; 🇬🇧 Leicester, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Royal Devon and Exeter Hospital; 🇬🇧 Exeter, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Sunderland Royal Hospital; 🇬🇧 Sunderland, United Kingdom

Worcestershire Royal Hospital; 🇬🇧 Worcester, United Kingdom

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom

Birmingham Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Golden Jubilee National Hospital; 🇬🇧 Glasgow, United Kingdom

Kettering General Hospital; 🇬🇧 Kettering, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

York Hospital; 🇬🇧 York, United Kingdom

Dorset County Hospital; 🇬🇧 Dorchester, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

The James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom

Barts Heart Centre; 🇬🇧 London, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

Royal Oldham Hospital; 🇬🇧 Oldham, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom

Salisbury District Hospital; 🇬🇧 Salisbury, United Kingdom

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

Lister Hospital; 🇬🇧 Stevenage, United Kingdom

Pinderfields Hospital; 🇬🇧 Wakefield, United Kingdom

New Cross Hospital; 🇬🇧 Wolverhampton, United Kingdom

Worthing Hospital; 🇬🇧 Worthing, United Kingdom

Wythenshawe Hospital; 🇬🇧 Wythenshawe, United Kingdom

Guy's and St Thomas' Hospital; 🇬🇧 London, United Kingdom

St George's Hospital; 🇬🇧 London, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom