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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01920048
Recruitment Status : Active, not recruiting
First Posted : August 9, 2013
Last Update Posted : May 4, 2020
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

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

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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
Actual Primary Completion Date : March 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

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


Locations
Show Show 40 study locations
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
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    
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: May 4, 2020
Last Verified: May 2020
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