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Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure (REVIVED-BCIS2)

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ClinicalTrials.gov Identifier: NCT01920048
Recruitment Status : Recruiting
First Posted : August 9, 2013
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
University of York
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Divaka Perera, King's College London

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Procedure: Percutaneous Coronary Intervention Drug: Drug Therapy for Heart Failure Device: Device Therapy for Heart Failure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Percutaneous Coronary Intervention and Optimal Medical Therapy Procedure: Percutaneous Coronary Intervention
Other Name: Coronary angioplasty/stents

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.
Active Comparator: Optimal Medical Therapy alone 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


Outcome Measures
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Primary Outcome Measures :
  1. All-cause death or Hospitalization for Heart Failure [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]

Secondary Outcome Measures :
  1. Quality of Life Scores and Functional Status [ Time Frame: 6 months, 1 year, 2 years ]
  2. Left Ventricular Ejection Fraction [ Time Frame: 6 months, 1 year ]
  3. Cardiovascular Death [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
  4. Appropriate Implantable Cardioverter Defibrillator Therapy [ Time Frame: 6 months, 1 year, 2 years ]
  5. Acute Myocardial Infarction [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
  6. Unplanned further revascularization [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
  7. Brain-type Natriuretic Peptide level [ Time Frame: 6 months, 1 year, 2 years ]
  8. Major Bleeding [ Time Frame: 6 months, 1 year, 2 years ]

Other Outcome Measures:
  1. Health Service Resource Use [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
    Health Economic Analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920048


Contacts
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Contact: Ruth Canter +44 (0)20 7927 2071 Ruth.Canter@lshtm.ac.uk
Contact: Richard Evans +44 (0)20 7927 2665 Richard.Evans@lshtm.ac.uk

Locations
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United Kingdom
Basingstoke and North Hampshire Hospital Recruiting
Basingstoke, United Kingdom, RG24 9NA
Contact: Susana Senra       susana.senra@hhft.nhs.uk   
Royal Victoria Hospital Recruiting
Belfast, United Kingdom, BT12 6BA
Contact: Patricia Glover       patricia.glover@belfasttrust.hscni.net   
Birmingham Heartlands Hospital Active, not recruiting
Birmingham, United Kingdom, B9 5SS
Blackpool Victoria Hospital Recruiting
Blackpool, United Kingdom, FY3 8NR
Contact: Natalia Waddington       natalia.waddington@nhs.net   
North Wales Cardiac Centre Recruiting
Bodelwyddan, United Kingdom, LL18 5UJ
Contact: Jill Andrews       Jillian.Andrews@wales.nhs.uk   
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Contact: Sarah Kennard       Cardiac.Research@rbch.nhs.uk   
Bristol Heart Institute Recruiting
Bristol, United Kingdom, BS2 8HW
Contact: Kalpa De Silva       Kalpa.desilva@nhs.net   
University Hospital Coventry Recruiting
Coventry, United Kingdom, CV2 2DX
Contact: Catherine Gibson       Catherine.Gibson2@uhcw.nhs.uk   
Dorset County Hospital Recruiting
Dorchester, United Kingdom, DT1 2JY
Contact: Jenny Birch       Jenny.Birch@dchft.nhs.uk   
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Anita Hutcheon       anitahutcheon@nhs.net   
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Belinda Rif       belinda.rif@nhslothian.scot.nhs.uk   
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Sam Keenan       samantha.keenan@nhs.net   
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom, G81 4DY
Contact: Marion McAdam       Marion.McAdam@gjnh.scot.nhs.uk   
Wycombe Hospital Withdrawn
High Wycombe, United Kingdom, HP11 2TT
Kettering General Hospital Recruiting
Kettering, United Kingdom, NN16 8UZ
Contact: Sian Sidgwick       sian.sidgwick@kgh.nhs.uk   
Leeds General Infirmary Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Michelle Anderson       michelle.anderson13@nhs.net   
Glenfield Hospital Recruiting
Leicester, United Kingdom, LE3 9QP
Contact: Manju Abraham       manjumol.abraham@uhl-tr.nhs.uk   
Liverpool Heart and Chest Hospital Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Nichola Clarkson       Nichola.Clarkson@lhch.nhs.uk   
Barts Heart Centre Recruiting
London, United Kingdom, EC1A 7BE
Contact: Oliver Mitchelmore       Oliver.Mitchelmore@bartshealth.nhs.uk   
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Nina Davies       nina.davies11@nhs.net   
Guy's and St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Amy Raynsford       Amy.Raynsford@gstt.nhs.uk   
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Jonathan Breeze       jonathan.breeze@nhs.net   
St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Contact: Giovanna Bonato       gbonato@sgul.ac.uk   
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Anu Oommen       Anu.oommen@cmft.nhs.uk   
The James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Cath Richardson       cath.richardson@nhs.net   
Freeman Hospital Recruiting
Newcastle, United Kingdom, NE7 7DN
Contact: Vera Wealleans       Vera.Wealleans@nuth.nhs.uk   
Royal Oldham Hospital Active, not recruiting
Oldham, United Kingdom, OL1 2JH
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Natasha Wilmshurst       natasha.wilmshurst@nhs.net   
Queen Alexandra Hospital Recruiting
Portsmouth, United Kingdom, PO6 3LY
Contact: Rosalynn Austin       Rosalynn.Austin@porthosp.nhs.uk   
Salisbury District Hospital Recruiting
Salisbury, United Kingdom, SP2 8BJ
Contact: Sophia Guimaraes       sophia.guimaraes@nhs.net   
Northern General Hospital Active, not recruiting
Sheffield, United Kingdom, S5 7AU
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Sam Gough       Sam.Gough@uhs.nhs.uk   
Lister Hospital Recruiting
Stevenage, United Kingdom, SG1 4AB
Contact: Claire Barratt       cardiologytrials.enh-tr@nhs.net   
Sunderland Royal Hospital Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Pauline Oates       Pauline.Oates@chsft.nhs.uk   
Great Western Hospital Recruiting
Swindon, United Kingdom, SN3 6BB
Contact: Laura McCafferty       laura.mccafferty2@nhs.net   
Pinderfields Hospital Recruiting
Wakefield, United Kingdom, WF1 4DG
Contact: Donna Exley       donna.exley@midyorks.nhs.uk   
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Stella Metherell       stella.metherell@nhs.net   
Worcestershire Royal Hospital Recruiting
Worcester, United Kingdom, WR5 1DD
Contact: Angela Doughty       a.doughty@nhs.net   
Worthing Hospital Recruiting
Worthing, United Kingdom, BN11 2DH
Contact: Raquel Gomez       raquel.gomez@wsht.nhs.uk   
Wythenshawe Hospital Recruiting
Wythenshawe, United Kingdom, M23 9LT
Contact: Sarra Giannopoulou       sarra.giannopoulou@mft.nhs.uk   
York Hospital Active, not recruiting
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
King's College London
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
University of York
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Divaka Perera, MB BChir, MA, MD, FRCP King's College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Divaka Perera, Consultant Cardiologist and Reader in Interventional Cardiology, King's College London
ClinicalTrials.gov Identifier: NCT01920048     History of Changes
Other Study ID Numbers: ISRCTN45979711
ISRCTN45979711 ( Other Identifier: International Standard Randomised Controlled Trial Number Register )
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Keywords provided by Divaka Perera, King's College London:
Heart Failure
Ventricular Dysfunction
Ischemic Cardiomyopathy
Ischemic Heart Disease
 Revascularization
Percutaneous Coronary Intervention
Randomized Control Trial
Implantable Cardioverter Defibrillator
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Ventricular Dysfunction
Ischemia
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes