REVascularisation for Ischaemic VEntricular Dysfunction
| ISRCTN | ISRCTN45979711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45979711 |
| ClinicalTrials.gov number | NCT01920048 |
| Secondary identifying numbers | HTA 10/57/67 |
- Submission date
- 20/11/2012
- Registration date
- 20/11/2012
- Last edited
- 22/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 March 2022 (updated 15/06/2021, previously: 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
Contact information
Scientific
King's College London
The Rayne Institute
Lambeth Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
| Divaka.Perera@kcl.ac.uk |
Public
Clinical Trials Unit (CTU)
Department of Medical Statistics
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
 ORCID ID |
0000-0003-0916-2551 |
|---|---|
| Phone | +44 20 7927 2071 |
| Ruth.Canter@lshtm.ac.uk |
Study information
| Study design | Multi-centre phase III randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | REVascularisation for Ischaemic VEntricular Dysfunction |
| Study acronym | REVIVED |
| Study hypothesis | Current study hypothesis as of 21/04/2022: Compared to medical therapy alone, PCI improves event-free survival in patients with ischaemic cardiomyopathy and viable myocardium. More details and the latest version of the Protocol can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/105767#/ Previous 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(s) | Westminster Research Ethics Committee, 13/09/2010, bref: 10/H0802/46 |
| 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 |
| Primary outcome measure | Current primary outcome measure as of 23/10/2018: A composite of all-cause death and hospitalisation due to heart failure with a minimum follow-up of 2 years and maximum follow-up of approximately 8.5 years depending on time of randomisation. Previous 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 | Current secondary outcome measures as of 21/04/2022: 1. Left Ventricular Ejection Fraction (LVEF) on echocardiography at 6 months and 1 year 2. Quality of life score: 2.1. Kansas City Cardiomyopathy questionnaire (KCCQ) up to 2 years 2.2. EuroQol EQ-5D-5L at 6 months and then yearly to the end of follow-up 3. New York Heart Association Functional (NYHA) Class up to 2 years 4. Cardiovascular death over the entire duration of follow-up 5. All-cause death over the entire duration of follow-up 6. Hospitalisation due to heart failure over the entire duration of follow-up 7. Acute myocardial infarction (MI) over the entire duration of follow-up 8. Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years 9. Unplanned further revascularisation over the entire duration of follow-up 10. Canadian Cardiovascular Society (CCS) up to 2 years 11. NHS resource use 12. Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years 13. Major bleeding up to 2 years Previous 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 study start date | 01/05/2013 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 700 |
| Total final enrolment | 700 |
| 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 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 | 19/03/2020 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
SE5 9RS
United Kingdom
RG24 9NA
United Kingdom
FY3 8NR
United Kingdom
PL6 8DH
United Kingdom
DT1 2JY
United Kingdom
NE7 7DN
United Kingdom
Rhyl
LL30 1LB
United Kingdom
LE3 9QP
United Kingdom
G81 4DY
United Kingdom
SN3 6BB
United Kingdom
NN16 8UZ
United Kingdom
LS1 3EX
United Kingdom
SG1 4AB
United Kingdom
L14 3PE
United Kingdom
M13 9WL
United Kingdom
WV10 0QP
United Kingdom
DD1 9SY
United Kingdom
WF1 4DG
United Kingdom
PO6 3LY
United Kingdom
BH7 7DW
United Kingdom
EX2 3DW
United Kingdom
NW3 2PF
United Kingdom
EH16 4SA
United Kingdom
OL1 2JH
United Kingdom
BT12 6BA
United Kingdom
SP2 8BJ
United Kingdom
SO16 6YD
United Kingdom
EC1A 7BE
United Kingdom
SW17 0QT
United Kingdom
SE1 7EH
United Kingdom
SR4 7TP
United Kingdom
TS4 3BW
United Kingdom
CV2 2DX
United Kingdom
WR5 1DD
United Kingdom
BN11 2DH
United Kingdom
M23 9QZ
United Kingdom
Bristol
BS2 8HW
United Kingdom
B9 5SS
United Kingdom
YO31 8HE
United Kingdom
S5 7AU
United Kingdom
Sponsor information
University/education
c/o Professor Reza Razavi
King’s College London
Room 5.31A
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)207 8483224 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Hospital/treatment centre
St Thomas' Hospital
Westminster Bridge Rd
Lambeth
London
SE1 7EH
England
United Kingdom
| crf@gstt.nhs.uk |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We plan to publish the trial results in a high-impact peer-reviewed journal and present the results at an international cardiology conference. We also plan to disseminate the results to the trial participants, recruiting hospitals, relevant PPI groups, and the relevant local, national, and international clinical and regulatory bodies. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2018 | 19/11/2019 | Yes | No |
| Results article | primary composite outcome of death from any cause or hospitalization for heart failure | 13/10/2022 | 22/12/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/12/2022: Publication reference added.
21/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/03/2020 to 19/03/2020.
2. The overall trial end date has been changed from 30/03/2022 to 31/03/2022.
3. The study hypothesis has been updated.
4. The secondary outcome measures has been updated.
5. The trial participating centres “Birmingham Heartlands Hospital”, "York Hospital", and “Northern General Hospital” have been added and the trial participating centre “Glan Clwyd Hospital” has been updated.
6. The publication and dissemination plan has been added.
7. The individual participant data (IPD) sharing statement has been added and the IPD sharing summary has been changed from "Not provided at time of registration" to "Data sharing statement to be made available at a later date".
15/06/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 04/05/2020 to 30/03/2020.
2. The overall end date was changed from 31/12/2022 to 30/03/2022.
3. The intention to publish date was changed from 31/12/2020 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
5. The total final enrolment was added.
05/05/2020: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2022 to 04/05/2020.
2. Bristol Royal Infirmary has been added to the trial participating centres.
3. The intention to publish date has been changed from 01/06/2020 to 31/12/2020.
19/11/2019: Publication reference added.
23/10/2018: The following changes have been made:
1. The primary outcome measure has been changed.
2. The sponsor has been changed from Guy's Hospital to Kings College London and Guy’s and St Thomas’ NHS Foundation Trust.
3. The sponsor contact has been changed from Keith Brennan to Prof Reza Razavi.
4. Basingstoke and North Hampshire Hospital, Blackpool Victoria Hospital, Derriford Hospital, Dorset County Hospital, Freeman Hospital, Glan Clwyd Hospital, Glenfield Hospital, Golden Jubilee National Hospital, Great Western Hospital, Kettering General Hospital, King’s College Hospital, Leeds General Infirmary, Lister Hospital, Liverpool Heart and Chest Hospital, Manchester Royal Infirmary, New Cross Hospital, Ninewells Hospital, Pinderfields Hospital, Queen Alexandra Hospital, Royal Bournemouth Hospital, Royal Devon and Exeter Hospital, Royal Free Hospital, Royal Infirmary of Edinburgh, Royal Oldham Hospital, Royal Victoria Hospital, Salisbury District Hospital, Southampton General Hospital, St Bartholomew’s Hospital, St George’s Hospital, St Thomas' Hospital, Sunderland Royal Hospital, The James Cook University Hospital, University Hospital Coventry, Worcestershire Royal Hospital, Worthing Hospital and Wythenshawe Hospital have been added as trial centres.
5. A public contact has been added.
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
