Study identification

PURI

https://redirect.ema.europa.eu/resource/36264

EU PAS number

EUPAS13835

Study ID

36264

Official title and acronym

Assessment of Real LIfe cAre – Describing EuropeaN Heart FailurE Management (ARIADNE)

DARWIN EU® study

No

Study countries

Austria
Belgium
Bulgaria
Cyprus
Estonia
France
Germany
Greece
Ireland
Israel
Italy
Malta
Norway
Poland
Portugal
Romania
Russian Federation
Slovakia
Spain
Switzerland
United Kingdom

Study description

This is an observational, European NIS with prospective collection of primary data. Data will be collected for two groups of HFrEF patients: symptomatic patients who receive the current individualized standard of care (SoC) for the treatment of CHF and patients for whom the physician has decided to prescribe sacubitril/valsartan. Switching between different CHF treatments (e.g. between SoC and sacubitril/valsartan) is allowed at any time as per decision of the investigator. Enrollment will start in each country when sacubitril/valsartan is available for clinical use. Overall the present NIS will enroll 6000 patients on SoC and 6000 patients on sacubitril/valsartan across Europe.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 999 centres are involved in the study

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis
Study protocol
Initial protocol

LCZ696B3401-redacted_protocol_final

English (679.81 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable