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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259711
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

Study Description
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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
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
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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 : January 2001
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : August 14, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Groups and Cohorts
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Intervention Details:
  • Drug: Hormonal therapies L02 in the ATC classification
    Hormonal therapies L02 in the ATC classification

Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Immediate evaluation ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: Immediate evaluation ]
  2. Disproportionality analysis of the reporting of drug-induced ventricular arrhythmia's with selective estrogen receptor modulators as compared to aromatase inhibitors [ Time Frame: Immediate evaluation ]
  3. Disproportionality analysis of the reporting of drug- induced QT prolongation with selective estrogen receptor modulators as compared to aromatase inhibitors [ Time Frame: Immediate evaluation ]
  4. Disproportionality analysis of the reporting of drug-induced Torsade de Pointe with selective estrogen receptor modulators as compared to aromatase inhibitors [ Time Frame: Immediate evaluation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population is selected in the Eurodravigilance database from 01/2002 to 08/2017 and included patients treated with hormonal therapies L02 in the ATC classification.
Criteria

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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259711


Locations
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France
Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
Paris, Ile De France, France
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Investigators
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Principal Investigator: Joe-Elie Salem, MD, PhD Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
More Information
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Publications of Results:

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Responsible Party: Joe Elie Salem, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03259711    
Other Study ID Numbers: CIC1421-17-09
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
Cardiotoxicity
selective estrogen receptor modulators
aromatase inhibitors
hormone replacement therapy
estrogen
Additional relevant MeSH terms:
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Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries