PREEMPT HF
Research type
Research Study
Full title
PREcision Event Monitoring of PatienTs with Heart Failure using HeartLogic™
IRAS ID
249657
Contact name
Roy Gardner
Contact email
Sponsor organisation
Guidant Europe, a Boston Scientific Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 5 months, 1 days
Research summary
Research Summary
The PREEMPT HF study is designed to collect data from implantable defibrillators (ICD) and cardiac resynchronisation therapy defibrillators (CRTD) in those patients at risk of sudden cardiac death or worsening heart failure. ICD and CRTD manufactured by Boston Scientific contain a feature called HeartLogic™. Both Boston Scientific ICD’s and CRTD’s, along with the HeartLogic™ feature are commercially available and routinely used in NHS hospitals.
The implantation of either an ICD or CRTD is not within the scope of this study. Patients recruited will already have received a qualifying device.
The study intends to collect data that is automatically stored within the devices and to compare it with medical record data if and when an enrolled patient undergoes invasive treatment for heart failure or is admitted to hospital for heart failure. Device data is automatically transmitted from the patient’s implanted device via a system called LATITUDE. LATITUDE consists of a transmitter that is kept in the patient’s home which downloads device data and sends it to a secure web based application for hospital staff to review. By using LATITUDE, the patients are not required to attend any additional hospital visits for data retrieval.
The hospital is required to provide relevant data relating to heart failure admissions to the study Sponsor so that it may be compared to the data obtained remotely from the ICD/CRTD. Patients are asked to notify the study team of any hospital admissions but are not required to attend any extra visits for the study. To ensure that admissions are not missed, the study team will perform a review of the patient’s medical file after 6 months in the study.
The Sponsor will use the data to enhance the HeartLogic™ feature so that it can provide accurate early alerts to hospital staff that will indicate worsening heart failure. It is expected that such alerts will lead to earlier intervention thus reducing heart failure admissions in this patient group.
Summary of Results
Heart failure (HF) is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic HF is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of HF and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators (CRT-Ds and ICDs), combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity.
The goal of the PREEMPT-HF study was to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
PREEMPT-HF has fulfilled this objective by enrolling 2183 subjects and collecting usable device data, including heart failure sensor measurements, together with clinical event data. This data collection is expected to allow extensive evaluation of future applications of heart failure sensor measurements in relation to Reviewable Clinical Events.
For more information about the study publications find the results published on: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzprNwMDHu77yaGAOwAcM2nEufUF-2BRzIaR7hSRO8Yr9V6H1yvIPawitEtIvhGVVRutQCaG_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK2Qz4aHoXv8MzPFgSHLbRddNvE2Y32ff-2FLrjOaKJdHEwEJHDDGCT-2BEtvQ2-2Fw-2BPvKK7rZRnj7MH-2F7OScieI9XYbrvoLbd5qtPg3jU4US1c86riZqZ9m55XJlfSsecAukBRIs-2FV0CaVPwMQT8D-2BFOOoPn-2FZipGcXZRrlhpNw1yIU2w-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C10e8f7efb8044f9192c908dafaf1ffef%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638098214542322200%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=0K7WF5JvHgueYlIqQaTAWjQ1eLTGbjUR1BhPKABiGIc%3D&reserved=0
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1370
Date of REC Opinion
27 Jul 2018
REC opinion
Favourable Opinion