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

Cardiac Affections Clinical Trial

— SERENA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259711
• Other study ID #: CIC1421-17-09
• Status: Completed
• Start date: January 2001
• Est. completion date: August 14, 2017

Study information

• Verified date: October 2018
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Cardiac Affections
• Cardiotoxicity

Intervention

Drug:
• Hormonal therapies L02 in the ATC classification
Hormonal therapies L02 in the ATC classification

Locations

Country	Name	City	State
France	Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

References & Publications (1)

Grouthier V, Lebrun-Vignes B, Glazer AM, Touraine P, Funck-Brentano C, Pariente A, Courtillot C, Bachelot A, Roden DM, Moslehi JJ, Salem JE. Increased long QT and torsade de pointes reporting on tamoxifen compared with aromatase inhibitors. Heart. 2018 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Disproportionality analysis of the reporting of drug-induced ventricular arrhythmia's with selective estrogen receptor modulators as compared to aromatase inhibitors		Immediate evaluation
Secondary	Disproportionality analysis of the reporting of drug- induced QT prolongation with selective estrogen receptor modulators as compared to aromatase inhibitors		Immediate evaluation
Secondary	Disproportionality analysis of the reporting of drug-induced Torsade de Pointe with selective estrogen receptor modulators as compared to aromatase inhibitors		Immediate evaluation