Clinical Trials/NCT01920048

NCT01920048

Completed

N/A

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

King's College London40 sites in 1 country700 target enrollmentAugust 28, 2013

ConditionsIschemic Cardiomyopathy

InterventionsPercutaneous Coronary Intervention Drug Therapy for Heart Failure Device Therapy for Heart Failure

DrugsDrug Therapy for Heart Failure

Overview

Phase: N/A
Intervention: Percutaneous Coronary Intervention
Conditions: Ischemic Cardiomyopathy
Sponsor: King's College London
Enrollment: 700
Locations: 40
Primary Endpoint: All-cause death or Hospitalization for Heart Failure
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 28, 2013

End Date

March 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

King's College London

Responsible Party

Principal Investigator

Divaka Perera

Consultant Cardiologist and Professor of Cardiology

King's College London

Eligibility Criteria

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

Arms & Interventions

Percutaneous Coronary Intervention and Optimal Medical Therapy

Intervention: Percutaneous Coronary Intervention

Percutaneous Coronary Intervention and Optimal Medical Therapy

Intervention: Drug Therapy for Heart Failure

Percutaneous Coronary Intervention and Optimal Medical Therapy

Intervention: Device Therapy for Heart Failure

Optimal Medical Therapy alone

Intervention: Drug Therapy for Heart Failure

Optimal Medical Therapy alone

Intervention: Device Therapy for Heart Failure

Outcomes

Primary Outcomes

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

Hospitalization due to heart failure(1 to 103 months (min follow-up duration: 24 months))
Quality of Life Scores(6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years)
Left Ventricular Ejection Fraction(6 months, 1 year)
Cardiovascular Death(1 to 103 months (min follow-up duration: 24 months))
All-cause death(1 to 103 months (min follow-up duration: 24 months))
Appropriate Implantable Cardioverter Defibrillator Therapy(6 months, 1 year, 2 years)
Unplanned further revascularization(1 to 103 months (min follow-up duration: 24 months))
Canadian Cardiovascular Society class(6 months, 1 year, 2 years)
Brain-type Natriuretic Peptide level(6 months, 1 year, 2 years)
New York Heart Association Functional (NYHA) Class(6 months, 1 year, 2 years)
Acute Myocardial Infarction(1 to 103 months (min follow-up duration: 24 months))
Major Bleeding(6 months, 1 year, 2 years)