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

Ischemic Cardiomyopathy Clinical Trial

— REVIVED-BCIS2  

Official title:

REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED): a Randomized Comparison of Percutaneous Coronary Intervention (With Optimal Medical Therapy) Versus Optimal Medical Therapy Alone for Treatment of Heart Failure Secondary to Coronary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920048
• Other study ID #: ISRCTN45979711
• Secondary ID: ISRCTN45979711
• Status: Completed
• Phase: N/A
• Start date: August 28, 2013
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: March 31, 2022
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemia
• Ischemic Cardiomyopathy
• Ventricular Dysfunction

Intervention

Procedure:
• Percutaneous Coronary Intervention

Drug:
• Drug 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

Device:
• Device 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.

Locations

Country	Name	City	State
United Kingdom	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	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Kettering General Hospital	Kettering
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Barts Heart Centre	London
United Kingdom	Guy's and St Thomas' Hospital	London
United Kingdom	King's College Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	The James Cook University Hospital	Middlesbrough
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	Southampton General Hospital	Southampton
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	Great Western Hospital	Swindon
United Kingdom	Pinderfields Hospital	Wakefield
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Worcestershire Royal Hospital	Worcester
United Kingdom	Worthing Hospital	Worthing
United Kingdom	Wythenshawe Hospital	Wythenshawe
United Kingdom	York Hospital	York

Sponsors (5)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust, London School of Hygiene and Tropical Medicine, National Institute for Health Research, United Kingdom, University of York

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NHS Resource Use	Health Economic Analysis	1 to 103 months (min follow-up duration: 24 months)
Primary	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	1 to 103 months (min follow-up duration: 24 months)
Secondary	Left Ventricular Ejection Fraction	Left Ventricular Ejection Fraction (LVEF) on echocardiography	6 months, 1 year
Secondary	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.	6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
Secondary	New York Heart Association Functional (NYHA) Class		6 months, 1 year, 2 years
Secondary	Cardiovascular Death	Cardiovascular death over the entire duration of follow-up	1 to 103 months (min follow-up duration: 24 months)
Secondary	All-cause death	All-cause death over the entire duration of follow-up	1 to 103 months (min follow-up duration: 24 months)
Secondary	Hospitalization due to heart failure	Hospitalization due to heart failure over the entire duration of follow-up	1 to 103 months (min follow-up duration: 24 months)
Secondary	Acute Myocardial Infarction	Acute myocardial infarction (MI) over the entire duration of follow-up	1 to 103 months (min follow-up duration: 24 months)
Secondary	Appropriate Implantable Cardioverter Defibrillator Therapy	Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years	6 months, 1 year, 2 years
Secondary	Unplanned further revascularization	Unplanned further revascularization over the entire duration of follow-up	1 to 103 months (min follow-up duration: 24 months)
Secondary	Canadian Cardiovascular Society class	Canadian Cardiovascular Society (CCS) class up to 2 years	6 months, 1 year, 2 years
Secondary	Brain-type Natriuretic Peptide level	Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years	6 months, 1 year, 2 years
Secondary	Major Bleeding	Major bleeding up to 2 years	6 months, 1 year, 2 years