AzTrials
AzTrials

Ischemic CardiomyopathyREVIVED-BCIS2NCT01920048

Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure

A study testing Percutaneous Coronary Intervention, Drug Therapy for Heart Failure and Device Therapy for Heart Failure in people with Ischemic Cardiomyopathy, run by King's College London at 40 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Cardiomyopathy
What is being tested?
Percutaneous Coronary Intervention, Drug Therapy for Heart Failure and Device Therapy for Heart Failure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
40 sitesUnited Kingdom
Study dates
28 Aug 2013to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ALL of the following:
  • Poor left ventricular function (EF≤35%)
  • Extensive coronary disease
  • Viability in at least 4 dysfunctional segments that can be revascularised by PCI

Who cannot join

  • Myocardial infarction < 4 weeks prior to randomisation (clinical definition)
  • 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
  • Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges <72 hours prior to randomization
  • Valve disease requiring intervention
  • Contraindications to percutaneous coronary intervention
  • Age <18 yrs
Show all 10Show fewer
  • Estimated Glomerular Filtration Rate < 25 ml/min, unless established on dialysis
  • Women who are pregnant
  • Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
  • Life expectancy < 1 yr due to non-cardiac pathology

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United Kingdom40 sites
  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG24 9NA

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • North Wales Cardiac Centre

    Bodelwyddan, LL18 5UJ

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Bristol Heart Institute

    Bristol, BS2 8HW

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Golden Jubilee National Hospital

    Glasgow, G81 4DY

  • Kettering General Hospital

    Kettering, NN16 8UZ

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • Glenfield Hospital

    Leicester, LE3 9QP

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

  • Barts Heart Centre

    London, EC1A 7BE

  • Royal Free Hospital

    London, NW3 2QG

  • Guy's and St Thomas' Hospital

    London, SE1 7EH

  • King's College Hospital

    London, SE5 9RS

  • St George's Hospital

    London, SW17 0QT

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Royal Oldham Hospital

    Oldham, OL1 2JH

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Salisbury District Hospital

    Salisbury, SP2 8BJ

  • Northern General Hospital

    Sheffield, S5 7AU

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Lister Hospital

    Stevenage, SG1 4AB

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

  • Great Western Hospital

    Swindon, SN3 6BB

  • Pinderfields Hospital

    Wakefield, WF1 4DG

  • New Cross Hospital

    Wolverhampton, WV10 0QP

  • Worcestershire Royal Hospital

    Worcester, WR5 1DD

  • Worthing Hospital

    Worthing, BN11 2DH

  • Wythenshawe Hospital

    Wythenshawe, M23 9LT

  • York Hospital

    York, YO31 8HE

Other trials in United Kingdom

About this study

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

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.

Being tested
Percutaneous Coronary Intervention, Drug Therapy for Heart Failure, Device Therapy for Heart Failure
Keywords
Heart Failure, Ventricular Dysfunction, Ischemic Cardiomyopathy, Ischemic Heart Disease, Revascularization, Percutaneous Coronary Intervention, Randomized Control Trial, Implantable Cardioverter Defibrillator
Medical subject headings
Heart Failure, Ventricular Dysfunction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionProcedure or surgery

    Also called Coronary angioplasty/stents

  • Drug Therapy for Heart FailureDrug

    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 Therapy for Heart FailureDevice

    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.

Study groups in NCT01920048
Study groupRoleWhat they receive
Percutaneous Coronary Intervention and Optimal Medical TherapyExperimentalNot described
Receives: Procedure: Percutaneous Coronary Intervention; Drug: Drug Therapy for Heart Failure; Device: Device Therapy for Heart Failure
Optimal Medical Therapy aloneActive comparatorNot described
Receives: Drug: Drug Therapy for Heart Failure; Device: Device Therapy for Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause death or Hospitalization for Heart Failure

    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

    Measured: 1 to 103 months (min follow-up duration: 24 months)

Secondary outcomes (12)
  1. Left Ventricular Ejection Fraction

    Left Ventricular Ejection Fraction (LVEF) on echocardiography

    Measured: 6 months, 1 year

  2. Quality of Life Scores

    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.

    Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years

  3. New York Heart Association Functional (NYHA) Class

    Measured: 6 months, 1 year, 2 years

  4. Cardiovascular Death

    Cardiovascular death over the entire duration of follow-up

    Measured: 1 to 103 months (min follow-up duration: 24 months)

  5. All-cause death

    All-cause death over the entire duration of follow-up

    Measured: 1 to 103 months (min follow-up duration: 24 months)

  6. Hospitalization due to heart failure

    Hospitalization due to heart failure over the entire duration of follow-up

    Measured: 1 to 103 months (min follow-up duration: 24 months)

  7. Acute Myocardial Infarction

    Acute myocardial infarction (MI) over the entire duration of follow-up

    Measured: 1 to 103 months (min follow-up duration: 24 months)

  8. Appropriate Implantable Cardioverter Defibrillator Therapy

    Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years

    Measured: 6 months, 1 year, 2 years

  9. Unplanned further revascularization

    Unplanned further revascularization over the entire duration of follow-up

    Measured: 1 to 103 months (min follow-up duration: 24 months)

  10. Canadian Cardiovascular Society class

    Canadian Cardiovascular Society (CCS) class up to 2 years

    Measured: 6 months, 1 year, 2 years

  11. Brain-type Natriuretic Peptide level

    Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years

    Measured: 6 months, 1 year, 2 years

  12. Major Bleeding

    Major bleeding up to 2 years

    Measured: 6 months, 1 year, 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2013 (estimated)
  2. Study start28 Aug 2013
  3. Primary completion19 Mar 2020
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01920048
Sponsor's protocol ID
ISRCTN45979711
Other IDs
ISRCTN45979711
Acronym
REVIVED-BCIS2
Status last verified
May 2022
First submitted
3 Aug 2013
Last updated
31 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Ovesen C, Dodd M, Ryan M, Clayton T, Sharples L, Perera D. Impact of baseline risk of death or hospitalization on effectiveness of revascularization in patients with ischaemic left ventricular dysfunction-a prespecified analysis of REVIVED-BCIS2. Eur Heart J Qual Care Clin Outcomes. 2025 Dec 19;11(8):1440-1447. doi: 10.1093/ehjqcco/qcaf108.

    PubMed 40972554
  • Ezad SM, McEntegart M, Dodd M, Didagelos M, Sidik N, Li Kam Wa M, Morgan HP, Pavlidis A, Weerackody R, Walsh SJ, Spratt JC, Strange J, Ludman P, Chiribiri A, Clayton T, Petrie MC, O'Kane P, Perera D; REVIVED-BCIS2 Investigators. Impact of Anatomical and Viability-Guided Completeness of Revascularization on Clinical Outcomes in Ischemic Cardiomyopathy. J Am Coll Cardiol. 2024 Jul 23;84(4):340-350. doi: 10.1016/j.jacc.2024.04.043. Epub 2024 May 15.

    PubMed 38759904
  • Ryan M, Taylor D, Dodd M, Spertus JA, Kosiborod MN, Shaukat A, Docherty KF, Clayton T, Perera D, Petrie MC; REVIVED-BCIS2 Investigators. Effect of PCI on Health Status in Ischemic Left Ventricular Dysfunction: Insights From REVIVED-BCIS2. JACC Heart Fail. 2024 Sep;12(9):1553-1562. doi: 10.1016/j.jchf.2024.03.010. Epub 2024 Apr 8.

    PubMed 38727649
  • Chivardi C, Morgan H, Sculpher MJ, Clayton T, Evans R, Dodd M, Petrie M, Rinaldi CA, O'Kane P, Brown L, Perera D, Saramago P; REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction: Cost-Effectiveness Analysis of the REVIVED-BCIS2 Trial. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010533. doi: 10.1161/CIRCOUTCOMES.123.010533. Epub 2023 Nov 6.

    PubMed 37929587
  • Perera D, Ryan M, Morgan HP, Greenwood JP, Petrie MC, Dodd M, Weerackody R, O'Kane PD, Masci PG, Nazir MS, Papachristidis A, Chahal N, Khattar R, Ezad SM, Kapetanakis S, Dixon LJ, De Silva K, McDiarmid AK, Marber MS, McDonagh T, McCann GP, Clayton TC, Senior R, Chiribiri A; REVIVED-BCIS2 Investigators. Viability and Outcomes With Revascularization or Medical Therapy in Ischemic Ventricular Dysfunction: A Prespecified Secondary Analysis of the REVIVED-BCIS2 Trial. JAMA Cardiol. 2023 Dec 1;8(12):1154-1161. doi: 10.1001/jamacardio.2023.3803.

    PubMed 37878295
  • Perera D, Morgan HP, Ryan M, Dodd M, Clayton T, O'Kane PD, Greenwood JP, Walsh SJ, Weerackody R, McDiarmid A, Amin-Youssef G, Strange J, Modi B, Lockie T, Hogrefe K, Ahmed FZ, Behan M, Jenkins N, Abdelaal E, Anderson M, Watkins S, Evans R, Rinaldi CA, Petrie MC; REVIVED-BCIS2 Investigators. Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial. Circulation. 2023 Sep 12;148(11):862-871. doi: 10.1161/CIRCULATIONAHA.123.065300. Epub 2023 Aug 9.

    PubMed 37555345
  • Ezad SM, Ryan M, Perera D. Can Percutaneous Coronary Intervention Revive a Failing Heart? Heart Int. 2022 Dec 21;16(2):72-74. doi: 10.17925/HI.2022.16.2.72. eCollection 2022.

    PubMed 36741102
  • Perera D, Clayton T, O'Kane PD, Greenwood JP, Weerackody R, Ryan M, Morgan HP, Dodd M, Evans R, Canter R, Arnold S, Dixon LJ, Edwards RJ, De Silva K, Spratt JC, Conway D, Cotton J, McEntegart M, Chiribiri A, Saramago P, Gershlick A, Shah AM, Clark AL, Petrie MC; REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. N Engl J Med. 2022 Oct 13;387(15):1351-1360. doi: 10.1056/NEJMoa2206606. Epub 2022 Aug 27.

    PubMed 36027563
  • Perera D, Clayton T, Petrie MC, Greenwood JP, O'Kane PD, Evans R, Sculpher M, Mcdonagh T, Gershlick A, de Belder M, Redwood S, Carr-White G, Marber M; REVIVED investigators. Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy. JACC Heart Fail. 2018 Jun;6(6):517-526. doi: 10.1016/j.jchf.2018.01.024.

    PubMed 29852933

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention, Drug Therapy for Heart Failure and Device Therapy for Heart Failure in people with Ischemic Cardiomyopathy, run by King's College London at 40 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death or Hospitalization for Heart Failure (time frame: 1 to 103 months (min follow-up duration: 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01920048, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in