DARWIN EU® - Association between aliskiren use and the incidence of cardiac arrhythmia and/or sudden death

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001094
• Study ID:
  1000001094
• Official title and acronym:
  DARWIN EU® - Association between aliskiren use and the incidence of cardiac arrhythmia and/or sudden death
• DARWIN EU® study:
  Yes
• Study countries:
  Denmark

  Spain
• Study description:
  Existing evidence from case reports and preclinical data raised concerns regarding the atrial and ventricular proarrhythmic potential of aliskiren, especially with underlying risk of atrial fibrillation. However, current clinical evidence regarding the risk of cardiac arrhythmia and/or sudden death with aliskiren use is scarce
• Study status:
  Ongoing

Research institutions and networks

Institutions

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Italy

Netherlands

Norway

Portugal

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned:03/03/2026

Actual:03/05/2026

Study start date

Planned:02/07/2026

Actual:02/07/2026

Date of final study report

Planned:27/11/2026

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable