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REVascularisation for Ischaemic VEntricular Dysfunction
ISRCTN ISRCTN45979711
DOI 10.1186/ISRCTN45979711
ClinicalTrials.gov identifier NCT01920048
EudraCT number
Public title REVascularisation for Ischaemic VEntricular Dysfunction
Scientific title
Acronym REVIVED
Serial number at source HTA 10/57/67
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
Lay 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?
Rebecca Matthews
rebecca.matthews@LSHTM.ac.uk
Ethics approval Westminster Research Ethics Committee, 13/09/2010, bref: 10/H0802/46
Study design Multi-centre phase III randomised double-blind controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiology, Heart Failure
Participants - 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
Participants - exclusion criteria Current 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
Anticipated start date 01/05/2013
Anticipated end date 01/05/2018
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 600
Interventions Patients are randomised to receive either Optimal Medical Therapy (OMT) alone or Percutaneous Coronary Intervention (PCI) and OMT.
Primary outcome measure(s) 1. All-cause death
2. Acute myocardial infarction or hospitalisation due to heart failure (hierarchy: death > MI > heart failure).
Secondary outcome measure(s) 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
Sources of funding NIHR Health Technology Assessment - HTA (UK), ref: 10/57/67
Trial website
Publications
Contact name Dr  Divaka  Perera
  Address King's College London
The Rayne Institute,
Lambeth Wing
St Thomas' Hospital
  City/town London
  Zip/Postcode SE1 7EH
  Country United Kingdom
  Email Divaka.Perera@kcl.ac.uk
Sponsor Guy's Hospital (UK)
  Address c/o Mrs Karen Ignatian
R&D Department
16th Floor
Guy's Tower
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
  Sponsor website: http://www.guysandstthomas.nhs.uk/
Date applied 20/11/2012
Last edited 13/08/2014
Date ISRCTN assigned 20/11/2012
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