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22 May 2013
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| [ Print-friendly version ] |
| REVascularisation for Ischaemic VEntricular Dysfunction |
| ISRCTN | ISRCTN45979711 |
| DOI | 10.1186/ISRCTN45979711 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | REVascularisation for Ischaemic VEntricular Dysfunction |
| Scientific title | |
| Acronym | REVIVED |
| Serial number at source | REVIVED version 1.0 |
| Study hypothesis | Compared to medical therapy alone, PCI improves event free survival in patients with ischaemic cardiomyopathy and viable myocardium. |
| 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 the REVIVED 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, aged 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. 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? National Institute for Health Research - Health Technology Assessment Programme Who is the main contact? Richard Evans richard.evans@lshtm.ac.uk |
| Ethics approval | Westminster Research Ethics Committee, 13th September 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 |
1. LVEF ≤30%
2. Extensive coronary disease (BCIS-1 Jeopardy Score ≥6) 3. Viable myocardium in ≥30% of dysfunctional segments |
| Participants - 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 yrs 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 yr 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 |
| 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 | 20/11/2012 |
| Date ISRCTN assigned | 20/11/2012 |
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| © 2013 ISRCTN unless otherwise stated. | |
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