Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the CMV promoter (AAV1-CMV-SERCA2a), to heart failure patients that have received a left ventricular assist device (LVAD) for an accepted clinical indication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborators: British Heart Foundation; Celladon Corporation; Leducq Foundation

Criteria

Inclusion criteria

• Patients that have had a left ventricular assist device (LVAD) implanted for chronic heart failure, where chronic heart failure is defined as at least 6 months

• Patients are clinically stable in the opinion of the clinical team looking after the patient

• Written informed consent

Exclusion criteria

• <18 or >70 years of age at the time of consent

• Pregnancy or within 6 months of giving birth

• Women of child-bearing potential not using an effective method of contraception

• Men not using an effective method of contraception

• Suspected or active viral, fungal or parasitic infection within 48 hours prior to administration of IMP, in the opinion of the investigator*.

• Patients at a high risk of thrombosis in the opinion of the investigator

• Patients with a previous episode of LVAD thrombosis

• Patients with persistently raised lactate dehydrogenase (LDH >2.5 ULN)

• Patients requiring triple anticoagulation i.e. warfarin and dual anti-platelet

• Patients participating in another clinical trial

• Patients unable to comply with the protocol mandated procedures for social or other reasons, in the opinion of the investigator and primary care physician

• Eligible, enrolled and randomised patients who develop an infection will have study treatment delayed until 7 or more days after the time point when infection is no longer clinically evident.