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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College London
• Collaborators: Guy's and St Thomas' NHS Foundation Trust; London School of Hygiene and Tropical Medicine; London School of Hygiene and Tropical Medicine (Clinical Trials Unit); National Institute for Health Research, United Kingdom; University of York

Criteria

Inclusion Criteria:

ALL of the following:

1. Poor left ventricular function (EF≤35%)

2. Extensive coronary disease

3. Viability in at least 4 dysfunctional segments that can be revascularised by PCI

Exclusion Criteria:

1. Myocardial infarction < 4 weeks prior to randomisation (clinical definition)

2. 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

3. Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges <72 hours prior to randomization

4. Valve disease requiring intervention

5. Contraindications to percutaneous coronary intervention

6. Age <18 yrs

7. Estimated Glomerular Filtration Rate < 25 ml/min, unless established on dialysis

8. Women who are pregnant

9. Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data

10. Life expectancy < 1 yr due to non-cardiac pathology