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 type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  CAMZYOS

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3648

Study design details

• Main study objective:
  The main objective of this study is to estimate the incidence rates of heart failure (HF) associated with exposure to mavacamten and with exposure to non-mavacamten oHCM treatment, among adult patients with symptomatic oHCM and to estimate the risk of HF associated with exposure to mavacamten compared with non-mavacamten oHCM treatment, among adult patients with symptomatic oHCM.
• Outcomes:
  Incidence rate (IR) of Heart Failure (HF) Risk of HF, HF with systolic dysfunction Hospitalisation due to HF Non-fatal myocardial infarction (MI) Non-fatal stroke Arrhythmia Hospitalisation for arrhythmia Atrial fibrillation Atrial flutter Ventricular tachycardia Implanted cardioverter defibrillator therapy 3-point MACE 4-point MACE eMACE Cardiovascular mortality All-cause mortality
• Data analysis plan:
  Data analysis will be performed separately for each registry or database, using statistical packages SAS® Version 9.4 or higher (SAS Institute, Cary, NC, USA) or R (Version 3.5.0 or above), as appropriate. ; In the study reports, study results will be presented separately for each registry or database, as appropriate, per data availability. ; The complete study results for all registries/databases, including descriptive, comparative, exploratory, and sensitivity analyses, as well as the meta-analysis results (if feasible) will be provided in the final report. ; A full description of the analytical approach, data derivations, category definitions, analyses and presentation of the study results will be detailed in the SAP. ; The SAP will be finalised prior to the conduct of the study analyses.