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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by King's College London
Sponsor:
Collaborators:
National Institute for Health Research (Health Technology Assessment Programme)
London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
University of York (Centre for Health Economics)
Guy's and St Thomas' Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Divaka Perera, King's College London
ClinicalTrials.gov Identifier:
NCT01920048
First received: August 3, 2013
Last updated: June 15, 2015
Last verified: June 2015
  Purpose

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 Intervention
Ischemic Cardiomyopathy
Procedure: Percutaneous Coronary Intervention
Drug: Drug Therapy for Heart Failure
Device: Device Therapy for Heart Failure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • All-cause death or Hospitalization for Heart Failure [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life Scores and Functional Status [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Left Ventricular Ejection Fraction [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
  • Cardiovascular Death [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
  • Appropriate Implantable Cardioverter Defibrillator Therapy [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Acute Myocardial Infarction [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
  • Unplanned further revascularization [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
  • Brain-type Natriuretic Peptide level [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Major Bleeding [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Health Service Resource Use [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
    Health Economic Analysis


Estimated Enrollment: 700
Study Start Date: August 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920048

Contacts
Contact: Richard Evans +44 20 7927 2665 Richard.Evans@lshtm.ac.uk
Contact: Rosemary Knight +44 20 7927 2473 Rosemary.Knight@lshtm.ac.uk

Locations
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Alan Chung       alan.chung@heartofengland.nhs.uk   
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Contact: Sarah Kennard       Cardiac.Research@rbch.nhs.uk   
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Belinda Rif       belinda.rif@nhslothian.scot.nhs.uk   
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom, G81 4DY
Contact: Marion McAdam       Marion.McAdam@gjnh.scot.nhs.uk   
Kettering General Hospital Recruiting
Kettering, United Kingdom, NN16 8UZ
Contact: Charmaine Beirnes       Charmaine.Beirnes@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: Jo Hughes       joanna.hughes@uhl-tr.nhs.uk   
Liverpool Chest and Heart Hospital Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Jan Barton       Janet.Barton@lhch.nhs.uk   
Guy's and St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Lucy Clack    +44 20 7188 6271    Lucy.Clack@gstt.nhs.uk   
Contact: Sophie Jones    +44 20 7188 7188    Sophie.Jones@gstt.nhs.uk   
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Ava Williams       ava.williams@nhs.net   
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Angelique Smit       angelique.smit@nhs.net   
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Sarah Evans       sarah.evansmhc@cmft.nhs.uk   
James Cook University Hospital Not yet recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Cath Richardson       Catherine.Richardson@stees.nhs.uk   
Freeman Hospital Recruiting
Newcastle, United Kingdom, NE7 7DN
Contact: Alla Narytnyk       alla.narytnyk@nhs.net   
Queen Alexandra Hospital Not yet recruiting
Portsmouth, United Kingdom, PO6 3LY
Contact: Serena Howe       Serena.Howe2@porthosp.nhs.uk   
Northern General Hospital Recruiting
Sheffield, United Kingdom, S5 7AU
Contact: Joyce Fofie       Joyce.Fofie@sth.nhs.uk   
Southampton General Hospital Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Judy Radmore       Judith.Radmore@uhs.nhs.uk   
Lister Hospital Recruiting
Stevenage, United Kingdom, SG1 4AB
Contact: Claire Barratt       claire.barratt@nhs.net   
Sunderland Royal Hospital Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Pauline Oates       Pauline.Oates@chsft.nhs.uk   
Pinderfields Hospital Recruiting
Wakefield, United Kingdom, WF1 4DG
Contact: Judith Wright       Judith.Wright2@midyorks.nhs.uk   
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Andrew Smallwood       andy.smallwood@nhs.net   
Wycombe Hospital Not yet recruiting
Wycombe, United Kingdom, HP11 2TT
Contact: Nicola Bowers       Nicola.Bowers@buckshealthcare.nhs.uk   
Sponsors and Collaborators
King's College London
National Institute for Health Research (Health Technology Assessment Programme)
London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
University of York (Centre for Health Economics)
Guy's and St Thomas' Hospital NHS Foundation Trust
Investigators
Principal Investigator: Divaka Perera, MB BChir, MA, MD, FRCP King's College London
  More Information

No publications provided

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
Study First Received: August 3, 2013
Last Updated: June 15, 2015
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by 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:
Cardiomyopathies
Heart Failure
Ischemia
Ventricular Dysfunction
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 05, 2015