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 :
Active, not recruiting
First Posted : August 9, 2013
Last Update Posted : May 4, 2020
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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) |
| Estimated 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 |
| Study Start Date : | August 2013 |
| Actual Primary Completion Date : | March 2020 |
| Estimated Study Completion Date : | April 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 |
Primary Outcome Measures :
- All-cause death or Hospitalization for Heart Failure [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
Secondary Outcome Measures :
- Quality of Life Scores and Functional Status [ Time Frame: 6 months, 1 year, 2 years ]
- Left Ventricular Ejection Fraction [ Time Frame: 6 months, 1 year ]
- Cardiovascular Death [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
- Appropriate Implantable Cardioverter Defibrillator Therapy [ Time Frame: 6 months, 1 year, 2 years ]
- Acute Myocardial Infarction [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
- Unplanned further revascularization [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ]
- Brain-type Natriuretic Peptide level [ Time Frame: 6 months, 1 year, 2 years ]
- Major Bleeding [ Time Frame: 6 months, 1 year, 2 years ]
Other Outcome Measures:
- Health Service Resource Use [ Time Frame: 1 to 66 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 Reader in Interventional 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 4, 2020 |
| Last Verified: | May 2020 |
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 |