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Completed

NCT Number: NCT01920048

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

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.

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Key information

Conditions

Ischemic Cardiomyopathy Cardiovascular Diseases Heart Diseases Heart Failure Myocardial Ischemia Vascular Diseases Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basingstoke and North Hampshire Hospital, Basingstoke, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Percutaneous coronary intervention

Procedure

Other names: Coronary angioplasty/stents

Drug Therapy for Heart Failure

Drug

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 Failure

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Left Ventricular Ejection Fraction

    Time frame: 6 months, 1 year

    Left Ventricular Ejection Fraction (LVEF) on echocardiography

  2. 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.

  3. New York Heart Association Functional (NYHA) Class

    Time frame: 6 months, 1 year, 2 years

  4. Cardiovascular Death

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

    Cardiovascular death over the entire duration of follow-up

  5. 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

  6. 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

  7. 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

  8. Appropriate Implantable Cardioverter Defibrillator Therapy

    Time frame: 6 months, 1 year, 2 years

    Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years

  9. 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

  10. Canadian Cardiovascular Society class

    Time frame: 6 months, 1 year, 2 years

    Canadian Cardiovascular Society (CCS) class up to 2 years

  11. 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

  12. Major Bleeding

    Time frame: 6 months, 1 year, 2 years

    Major bleeding up to 2 years

Other outcomes

  1. NHS Resource Use

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

    Health Economic Analysis

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Guy's and St Thomas' NHS Foundation Trust
  • London School of Hygiene and Tropical Medicine
  • National Institute for Health Research, United Kingdom
  • University of York

Registry information

Official study 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

Acronym: REVIVED-BCIS2

Important dates

Study start
2013
Primary completion
2020
Study completion
2022
First posted
Aug 9, 2013
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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