ANTHEM
Research type
Research Study
Full title
Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Heart Failure with Reduced Ejection Fraction
IRAS ID
244390
Contact name
Neil Herring
Contact email
Sponsor organisation
Scirent Clinical Research & Science GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 28 days
Research summary
Research Summary- ANTHEM-HFrEF is a worldwide clinical study to test a new treatment for heart failure known as the VITARIA System. This device is designed to improve subjects heart function and to reduce heart failure symptoms by stimulating the vagus nerve, a long nerve from the brain which helps to maintain heart function.
2 out of 3 subjects will be randomly assigned to have the VITARIA device implanted in addition to their usual stable guideline-directed treatment (dose unchanged for 3 months prior to entering the study). This group of subjects is referred to as the ‘therapy or treatment group’. The remaining subjects will continue their usual stable guideline-directed medical therapy and will be referred to as the control arm or group.
Subjects in the therapy arm (VITARIA device plus usual guideline-directed treatment), will receive continuous, intermittent, stimulation to the vagus nerve after the surgery is completed, and will undergo visits for the therapy to be increased, or ‘up titrated’, over a period of 3 months. Subjects in the control arm (usual stable guideline-directed medical therapy) will also undergo scheduled visits at a similar frequency as the titration visits that are scheduled for subjects in the therapy arm.
The study will focus on the safety of the device, its effectiveness in preventing death and heart failure hospitalization, and the effect it may have on improving the heart’s pumping function and reducing heart failure symptoms. Data for safety and efficacy assessments will be collected for both study arms at 4 weeks post-implantation, every 3 months for the first 15/16 months, then every 4 monthly thereafter until the end of the study (up to 5 years).Summary of results- A lay summary will be provided after publication of the primary manuscript in a peer-reviewed medical journal.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0217
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion