Mavacamten Real-World Safety: a post-authorisation multi-national, long-term, observational study in patients with obstructive Hypertrophic Cardiomyopathy (oHCM) in the real-world setting in Europe (CV027-013)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/108179
• EU PAS number:
  EUPAS108178
• Study ID:
  108179
• Official title and acronym:
  Mavacamten Real-World Safety: a post-authorisation multi-national, long-term, observational study in patients with obstructive Hypertrophic Cardiomyopathy (oHCM) in the real-world setting in Europe (CV027-013)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  Sweden

  United Kingdom
• Study description:
  The aim of this study is to evaluate the risk of clinically important cardiovascular safety-related outcomes among adult patients with symptomatic oHCM receiving mavacamten compared to non-mavacamten oHCM treatment in a real-world setting in Europe.
• Study status:
  Planned

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 30/06/2024

Study start date

Planned: 31/03/2026

Data analysis start date

Planned: 31/03/2026

Date of final study report

Planned: 31/12/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)