SERENA: Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Completed

CT.gov ID

NCT03259711

Collaborator

(none)

20,000

Enrollment

Location

199.4

Actual Duration (Months)

100.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast cancer seems to have an impact on the cardio-vascular system. This study investigates reports of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification: L02 in the European pharmacovigilance database, Eudravigilance.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Affections	Drug: Hormonal therapies L02 in the ATC classification

Detailed Description

Hormone replacement therapies and contraceptive pills are responsible of a wide range of cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart disease. The difference of incidence and type of cardio-vascular events between men and women are strongly related to sex hormones. This study investigates the main characteristics of patients affected by cardiovascular side effects (of which ventricular arrhythmia's, QT prolongation and Torsade de Pointe) imputed to drugs classified as L02 according to ATC.

Study Design

Study Type:

Observational

Actual Enrollment :

20000 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Cardiotoxicity of Selective Estrogen Receptor Modulators and Aromatase Inhibitors in the European Pharmacovigilance Database

Actual Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Aug 14, 2017

Actual Study Completion Date :

Aug 14, 2017

Outcome Measures

Primary Outcome Measures

Analysis of disproportionality of reports for cardiotoxicity associated with selective estrogen receptor modulators as compared to aromatase inhibitors by performing a case- non-case study [Immediate evaluation]

Secondary Outcome Measures

Type of cardiotoxicity (ventricular arrhythmia's, QT prolongation and Torsade de Pointe) depending on the category and type of hormonal therapy (selective estrogen receptor modulators or aromatase inhibitors) [Immediate evaluation]
Disproportionality analysis of the reporting of drug-induced ventricular arrhythmia's with selective estrogen receptor modulators as compared to aromatase inhibitors [Immediate evaluation]
Disproportionality analysis of the reporting of drug- induced QT prolongation with selective estrogen receptor modulators as compared to aromatase inhibitors [Immediate evaluation]
Disproportionality analysis of the reporting of drug-induced Torsade de Pointe with selective estrogen receptor modulators as compared to aromatase inhibitors [Immediate evaluation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Case reported in the Eudravigilance from 01/2002 to 08/2017
Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the HLT Death and Sudden Death