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 August 2013 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: August 8, 2013
Last verified: August 2013
  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, myocardial infarction, cerebrovascular accident, major bleeding or unplanned revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 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≤30%)
  2. Extensive coronary disease (BCIS-1 Jeopardy Score ≥6)
  3. Viable myocardium in ≥30% of dysfunctional segments

Main Exclusion Criteria:

  1. Significant angina (≥Canadian Cardiovascular Society class 3)
  2. Myocardial infarction < 6 weeks previously

Other Exclusions

  1. 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
  2. Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Carioverter Defbrillator discharges <72 hours prior to randomization
  3. More than mild aortic stenosis or mild aortic regurgitation on echocardiography
  4. Contra-indications to percutaenous cornoary intervention, including contra-indications to Aspirin or Clopidogrel or Heparin
  5. Age <18 yrs
  6. Bleeding diathesis or Warfarin therapy with INR (International Normalized Ration)>3.5
  7. Active internal bleeding (except menstruation)
  8. Platelet count < 100,000 cells/mm3) at randomization
  9. Hemoglobin < 90 g/L at randomization
  10. Estimated Glomerular Filtration Rate < 25 ml/min, unless established on dialysis
  11. Women who are pregnant
  12. Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
  13. 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
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   
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: August 8, 2013
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:
Heart Failure
Ischemia
Cardiomyopathies
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014