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

May 27, 2022 updated by: Divaka Perera, King's College London

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke And North Hampshire Hospital
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Bodelwyddan, United Kingdom, LL18 5UJ
        • North Wales Cardiac Centre
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Heart Institute
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Dorchester, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Glasgow, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital
      • Kettering, United Kingdom, NN16 8UZ
        • Kettering General Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' Hospital
      • London, United Kingdom, EC1A 7BE
        • Barts Heart Centre
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Oldham, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury District Hospital
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stevenage, United Kingdom, SG1 4AB
        • Lister Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital
      • Wakefield, United Kingdom, WF1 4DG
        • Pinderfields Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Worcester, United Kingdom, WR5 1DD
        • Worcestershire Royal Hospital
      • Worthing, United Kingdom, BN11 2DH
        • Worthing Hospital
      • Wythenshawe, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • York, United Kingdom, YO31 8HE
        • York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Percutaneous Coronary Intervention and Optimal Medical Therapy
Procedure: Percutaneous Coronary Intervention
Other Names:
  • 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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause death or Hospitalization for Heart Failure
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
This composite endpoint will be collected over the entire duration of follow-up in the trial when the last patient randomized has reached 2 years of follow-up post randomization
1 to 103 months (min follow-up duration: 24 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Left Ventricular Ejection Fraction
Time Frame: 6 months, 1 year
Left Ventricular Ejection Fraction (LVEF) on echocardiography
6 months, 1 year
Quality of Life Scores
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
Kansas City Cardiomyopathy questionnaire (KCCQ) up to 2 years EuroQol EQ-5D-5L at 6 months and then yearly to the end of follow-up.
6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
New York Heart Association Functional (NYHA) Class
Time Frame: 6 months, 1 year, 2 years
6 months, 1 year, 2 years
Cardiovascular Death
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Cardiovascular death over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
All-cause death
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
All-cause death over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Hospitalization due to heart failure
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Hospitalization due to heart failure over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Acute Myocardial Infarction
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Acute myocardial infarction (MI) over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Appropriate Implantable Cardioverter Defibrillator Therapy
Time Frame: 6 months, 1 year, 2 years
Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years
6 months, 1 year, 2 years
Unplanned further revascularization
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Unplanned further revascularization over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Canadian Cardiovascular Society class
Time Frame: 6 months, 1 year, 2 years
Canadian Cardiovascular Society (CCS) class up to 2 years
6 months, 1 year, 2 years
Brain-type Natriuretic Peptide level
Time Frame: 6 months, 1 year, 2 years
Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years
6 months, 1 year, 2 years
Major Bleeding
Time Frame: 6 months, 1 year, 2 years
Major bleeding up to 2 years
6 months, 1 year, 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NHS Resource Use
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Health Economic Analysis
1 to 103 months (min follow-up duration: 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
London School of Hygiene and Tropical Medicine
Guy's and St Thomas' NHS Foundation Trust
National Institute for Health Research, United Kingdom
University of York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Divaka Perera, MB BChir, MA, MD, FRCP, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISRCTN45979711 (Other Identifier: International Standard Randomised Controlled Trial Number Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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