Assessment of real life care (ARIADNE)
Research type
Research Study
Full title
Assessment of real life care - describing European heart failure management (ARIADNE)
IRAS ID
173719
Contact name
Paul Kalra
Contact email
Sponsor organisation
Novartis Pharma Services AG
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Sacubitril/valsartan (also called LCZ696) constitutes the first of a new class of drugs – Angiotensin Receptor-Neprilysin Inhibitors (ARNIs) for the management of Heart Failure. In a recent phase III trial sacubitril/valsartan at a target dose of 200 mg twice a day reduced cardiovascular mortality by 20% compared to a evidence-based dose of the current standard of care (ACE inhibitor enalapril, 10 mg twice a day) with a comparable safety profile. However, it still appears extremely important to gather additional data on the use of sacubitril/valsartan and effectiveness in a real life setting, such as which patients are started on sacubitril/valsartan; the pattern of administration of the drug at start and the proportion of patients able
to tolerate the drug at different doses; the impact on healthcare resource utilization; quality of life (QoL); main efficacy and safety events in a real-life setting with a more diverse set of patients,The above mentioned questions will be addressed within the present prospective, non-interventional study. Up to 1200 UK chronic heart failure patients will participate at up to 60 sites.
Participants will be selected by the study sites and assessed for eligibility in line with inclusion criteria. Study assessments will occur at baseline and at approximately 6 and 12 months if this is the research site's routine practice.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1625
Date of REC Opinion
1 Sep 2016
REC opinion
Favourable Opinion