Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000351

EU PAS number

EUPAS1000000351

Study ID

1000000351

Official title and acronym

DARWIN EU® - Incidence of myoclonus in heart failure: a descriptive analysis in patients treated with sacubitril/valsartan and other treatments

DARWIN EU® study

Yes

Study countries

Germany
Spain
United Kingdom

Study description

Sacubitril/valsartan (Entresto) is an angiotensin receptor-neprilysin inhibitor used to treat symptomatic chronic heart failure in both adults and children. Its dual mechanism of action involves inhibiting neprilysin and blocking the angiotensin II type-1 receptor, providing complementary cardiovascular benefits. The Pharmacovigilance Risk Assessment Committee (PRAC) is currently investigating a signal on a potential association between the use of sacubitril/valsartan and myoclonus.
Through this study, we aimed to investigate the incidence rate of myoclonus in the general population, newly diagnosed heart failure patients and patients with heart failure initiating sacubitril/valsartan, angiotensin-converting enzyme inhibitors (ACEi), and angiotensin receptor blockers (ARBs).

This study aims to estimate incidence rates of myoclonus in different populations of interest.
Specific study objectives:
1. To calculate the incidence rate of myoclonus in a newly diagnosed heart failure population and the general population, stratified by age groups and sex.
2. To calculate the incidence rate of myoclonus in a heart failure population following first initiation of treatment cohorts: sacubitril/valsartan, angiotensin-converting enzyme inhibitors (ACEi), and angiotensin receptor blockers (ARBs) (index date being the start of the treatment).

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Julieta Politi

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-015_Sacubitril valsartan and risk of myoclonus V4.pdf

English (831.26 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable