Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure (REVIVED-BCIS2)
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| ClinicalTrials.gov Identifier: NCT01920048 |
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Recruitment Status :
Completed
First Posted : August 9, 2013
Last Update Posted : May 12, 2022
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Sponsor:
King's College London
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
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual 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 |
| Actual Study Start Date : | August 2013 |
| Actual Primary Completion Date : | March 2020 |
| Actual Study Completion Date : | March 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 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. |
Primary Outcome Measures :
- 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 Outcome Measures :
- Left Ventricular Ejection Fraction [ Time Frame: 6 months, 1 year ]Left Ventricular Ejection Fraction (LVEF) on echocardiography
- 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.
- New York Heart Association Functional (NYHA) Class [ Time Frame: 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
- 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
- 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
- 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
- Appropriate Implantable Cardioverter Defibrillator Therapy [ Time Frame: 6 months, 1 year, 2 years ]Appropriate implantable cardioverter defibrillator (ICD) therapy to 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
- Canadian Cardiovascular Society class [ Time Frame: 6 months, 1 year, 2 years ]Canadian Cardiovascular Society (CCS) class up to 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
- Major Bleeding [ Time Frame: 6 months, 1 year, 2 years ]Major bleeding up to 2 years
Other Outcome Measures:
- NHS Resource Use [ Time Frame: 1 to 103 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:
- 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
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 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
| 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):
| Responsible Party: | Divaka Perera, Consultant Cardiologist and Professor of 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 12, 2022 |
| Last Verified: | May 2022 |
Keywords provided by Divaka Perera, King's College London:
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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 |