Condition category
Circulatory System
Date applied
20/11/2012
Date assigned
20/11/2012
Last edited
14/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 14/09/2018:
Background and study aims
In 2002, it was estimated that approximately 900,000 individuals in the United Kingdom had a diagnosis of heart failure and at least 1 in 20 of all deaths here were related to this condition. There is evidence of an increase in heart failure in the population, with the number of associated hospital admissions expected to increase by around 50% in the next 25 years. This is the likely consequence of a progressively aging population and improved survival from acute coronary syndromes, partly due to more efficient and timely revascularisation techniques. Patients with heart failure are traditionally treated with a combination of tablets and (in some cases) by insertion of a special pacemaker. Together these treatments are called Optimal Medical Therapy (OMT). In patients who have heart failure as well as narrowed heart arteries, several recent studies have suggested that treatment of the narrowed arteries by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) may improve heart muscle pumping strength and heart failure symptoms. However, most of these studies have been too small or have not been scientific enough to allow widespread use of PCI or CABG as a treatment for heart failure. The purpose of this study is to assess whether treatment of heart arteries by angioplasty and stenting (PCI) in combination with OMT can improve heart muscle function, quality of life and life expectancy of patients, compared to OMT alone.

Who can participate?
Patients at least 18 years of age with poor heart pumping function and diseased arteries of the heart.

What does the study involve?
Patients will be randomly allocated to two treatment groups - either Percutaneous Coronary Intervention (PCI) and Optimal Medical Therapy (OMT), or to OMT alone.

What are the possible benefits and risks of participating?
As the benefit of treating narrowed arteries has not been clearly established yet, patients should assume that there would be no direct benefit to them. There is a very small risk of major complications during or shortly after the PCI procedure (including damage to an artery, heart attack, stroke or death). PCI procedures involve exposure to radiation in the form of X-rays, which can potentially be harmful.

Where is the study run from?
The trial will take place at approximately 35 centres in the UK. The main centre is Guy's & St Thomas' NHS Foundation Trust in London and will be coordinated from the London School of Hygiene and Tropical Medicine Clinical Trials Unit (LSHTM CTU).

When is the study starting and how long is it expected to run for?
Recruitment began in August 2013 and will continue until the end of April 2020. Follow-up will be for a minimum of two years, and the study is expected to finish in December 2022.

Who is the main contact?
Ruth Canter
ruth.canter@lshtm.ac.uk


Previous plain English summary:
Background and study aims
In 2002, it was estimated that approximately 900,000 individuals in the United Kingdom had a diagnosis of heart failure and at least 1 in 20 of all deaths here were related to this condition. There is evidence of an increase in heart failure in the population, with the number of associated hospital admissions expected to increase by around 50% in the next 25 years. This is the likely consequence of a progressively aging population and improved survival from acute coronary syndromes, partly due to more efficient and timely revascularisation techniques. Patients with heart failure are traditionally treated with a combination of tablets and (in some cases) by insertion of a special pacemaker. Together these treatments are called Optimal Medical Therapy (OMT). In patients who have heart failure as well as narrowed heart arteries, several recent studies have suggested that treatment of the narrowed arteries by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) may improve heart muscle pumping strength and heart failure symptoms. However, most of these studies have been too small or have not been scientific enough to allow widespread use of PCI or CABG as a treatment for heart failure. The purpose of this study is to assess whether treatment of heart arteries by angioplasty and stenting (PCI) in combination with OMT can improve heart muscle function, quality of life and life expectancy of patients, compared to OMT alone.

Who can participate?
Patients at least 18 years of age with poor heart pumping function and diseased arteries of the heart.

What does the study involve?
Patients will be randomly allocated to two treatment groups - either Percutaneous Coronary Intervention (PCI) and Optimal Medical Therapy (OMT), or to OMT alone.

What are the possible benefits and risks of participating?
As the benefit of treating narrowed arteries has not been clearly established yet, patients should assume that there would be no direct benefit to them. There is a very small risk of major complications during or shortly after the PCI procedure (including damage to an artery, heart attack, stroke or death). PCI procedures involve exposure to radiation in the form of X-rays, which can potentially be harmful.

Where is the study run from?
The trial will take place at approximately 25 centres in the UK. The main centre is Guy's & St Thomas' NHS Foundation Trust in London and will be coordinated from the clinical trial unit at London School of Hygiene and Tropical Medicine (UK).

When is study starting and how long is it expected to run for?
Recruitment will begin in May 2013 and continue until May 2016. Follow-up will be for a minimum of two years, and the study is expected to finish in May 2018.

Who is funding the study?
NIHR Health Technology Assessment - HTA (UK).

Who is the main contact?
Richard Evans
richard.evans@lshtm.ac.uk

Trial website

http://revived.lshtm.ac.uk

Contact information

Type

Scientific

Primary contact

Dr Divaka Perera

ORCID ID

Contact details

King's College London
The Rayne Institute
Lambeth Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
-
Divaka.Perera@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01920048

Protocol/serial number

HTA 10/57/67

Study information

Scientific title

REVascularisation for Ischaemic VEntricular Dysfunction

Acronym

REVIVED

Study hypothesis

Compared to medical therapy alone, PCI improves event-free survival in patients with ischaemic cardiomyopathy and viable myocardium.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/105767
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/81124/PRO-10-57-67.pdf

Ethics approval

Westminster Research Ethics Committee, 13/09/2010, bref: 10/H0802/46

Study design

Multi-centre phase III randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiology, heart failure

Intervention

Patients are randomised to receive either Optimal Medical Therapy (OMT) alone or Percutaneous Coronary Intervention (PCI) and OMT.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Current primary outcome measure as of 14/09/2018:
A composite of all-cause death and hospitalisation due to heart failure

Previous primary outcome measures:
1. All-cause death
2. Acute myocardial infarction or hospitalisation due to heart failure (hierarchy: death > MI > heart failure)

Secondary outcome measures

1. Cardiovascular death, MI, CVA or unplanned revascularisation at 30-days
2. Left ventricular ejection fraction at 6 months, 1 year
3. Cardiovascular death or myocardial infarction
4. Hospitalisation for heart failure
5. Appropriate ICD therapy
6. Unplanned further revascularisation
7. Acute coronary syndrome

Overall trial start date

01/05/2013

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 13/08/2014:
1. LVEF ≤35%
2. Extensive coronary disease (BCIS-1 Jeopardy Score ≥6)
3. Viability in at least 4 dysfunctional segments, that can be revascularised by PCI

Previous inclusion criteria:
1. LVEF ≤30%
2. Extensive coronary disease (BCIS-1 Jeopardy Score ≥6)
3. Viable myocardium in ≥30% of dysfunctional segments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant exclusion criteria

Current exclusion criteria as of 14/09/2018:
1. Myocardial infarction <4 weeks previously
2. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or IABP/left ventricular assist device (LVAD) therapy <72 hours prior to randomisation
3. Sustained VT/VF or appropriate ICD discharges <72 hours prior to randomisation
4. Valve disease requiring intervention
5. Contraindications to PCI
6. Aged <18 years
7. eGFR < 25 ml/min, unless established on dialysis
8. Women who are pregnant
9. Previously enrolled in REVIVED-BCIS2 or current enrolment in other trial that may affect REVIVED-BCIS2 outcome data
10. Life expectancy <1 year due to non-cardiac pathology

Previous exclusion criteria as of 13/08/2014:
Specific exclusions:
1. Significant angina (≥CCS class 3)
2. Myocardial infarction < 4 weeks previously

General exclusions:
1. Decompensated heart failure requiring inotropic support or IABP/LVAD therapy <72 hours prior to randomisation
2. Sustained VT/VF or appropriate ICD discharges <72 hours prior to randomisation
3. More than mild aortic stenosis or more than mild aortic regurgitation on echocardiography
4. Contra-indications to PCI
5. Age <18 years
6. eGFR < 25 ml/min, unless established on dialysis
7. Women who are pregnant
8. Previously enrolled in REVIVED or current enrolment in other study
9. Life expectancy < 1 year due to non-cardiac pathology

Previous exclusion criteria:
Specific exclusions:
1. Significant angina (≥CCS class 3)
2. Myocardial infarction < 6 weeks previously

General exclusions:
1. Decompensated heart failure requiring inotropic support or IABP/LVAD therapy <72 hours prior to randomisation
2. Sustained VT/VF or appropriate ICD discharges <72 hours prior to randomisation
3. More than mild aortic stenosis or mild aortic regurgitation on echocardiography
4. Contra-indications to PCI, including contra-indications to Aspirin or Clopidogrel or Heparin
5. Age <18 years
6. Bleeding diathesis or Warfarin therapy with INR>3
7. Active internal bleeding (except menstruation)
8. Platelet count < 100,000 cells/mm3) at randomisation
9. Haemoglobin < 9 g/dl at randomisation
10. eGFR < 25 ml/min, unless established on dialysis
11. Women who are pregnant
12. Previously enrolled in REVIVED or current enrolment in other study
13. Life expectancy < 1 year due to non-cardiac pathology

Recruitment start date

01/08/2013

Recruitment end date

30/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's Hospital (UK)

Sponsor details

c/o Mr Keith Brennan
R&D Department
16th Floor
Guy's Tower
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment - HTA (UK), ref: 10/57/67

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/06/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/09/2018: The following changes have been made: 1. The trial website has been added. 2. The primary outcome measure has been changed. 3. The overall trial end date has been changed from 01/05/2018 to 31/12/2022. 4. The total target enrolment has been changed from 600 to 700. 5. The participant exclusion criteria have been changed. 6. The recruitment start date has been changed from 01/05/2013 to 01/08/2013. 7. The recruitment end date has been changed from 01/05/2016 to 30/04/2022. 8. Karen Ignatian has been replaced as the sponsor contact by Keith Brennan. 9. The plain English summary has been changed. 26/08/2016: Internal review