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CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS) (TORNICS)

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ClinicalTrials.gov Identifier: NCT03193138
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of prostate 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: sex hormones (G03), hypothalamic hormones (H01C) and sex hormones used in treatment of neoplastic diseases (L02) in the French pharmacovigilance database and European Clinical Trials (EudraCT) database.

Condition or disease Intervention/treatment
Heart Diseases Drug: Hormonal therapies: G03, H01C and 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. Androgenic agonists and antagonists are used in various indication including prostate cancer or hormone replacement therapies. 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 G03, H01C and L02 according to ATC. A causality assessment according to both Begaud's method and the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied.

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Study Type : Observational
Actual Enrollment : 3096 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Cardiotoxicity of Androgenic Agonists and Antagonists in the National French Pharmacovigilance Database and EudraCT Database
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : June 21, 2017

Intervention Details:
  • Drug: Hormonal therapies: G03, H01C and L02 in the ATC classification
    Hormonal therapies including all therapies classified G03, H01C and L02 in the ATC classification


Primary Outcome Measures :
  1. Identification and report of the cardio-vascular toxicity of anti-androgenic therapies (reference G03 in the ATC classification) with a causality assessment using Begaud's and WHO's method. [ Time Frame: Immediate evaluation ]
    The research includes the report with MedDRA terms: System Organ Class (SOC) Cardiac Disorders and High Level Term (HLT) Death and Sudden Death. Drugs investigated are hormonal therapies with the reference G03 in the ATC classification

  2. Identification and report of the cardio-vascular toxicity of anti-androgenic therapies (reference H01C in the ATC classification) with a causality assessment using Begaud's and WHO's method. [ Time Frame: Immediate evaluation ]
    The research includes the report with MedDRA terms: System Organ Class (SOC) Cardiac Disorders and High Level Term (HLT) Death and Sudden Death. Drugs investigated are hormonal therapies with the reference H01C in the ATC classification

  3. Identification and report of the cardio-vascular toxicity of anti-androgenic therapies (reference L02 in the ATC classification) with a causality assessment using Begaud's and WHO's method. [ Time Frame: Immediate evaluation ]
    The research includes the report with MedDRA terms: System Organ Class (SOC) Cardiac Disorders and High Level Term (HLT) Death and Sudden Death. Drugs investigated are hormonal therapies with the reference L02 in the ATC classification


Secondary Outcome Measures :
  1. Causality assessment of reported cardiovascular events [ Time Frame: Immediate evaluation ]
    Causality assessment of reported cardiovascular events according to the WHO-UMC system

  2. Type of cardiotoxicity depending on the category and type of hormonal therapy [ Time Frame: Immediate evaluation ]
    Description of the type of cardiotoxicity depending on the category and type of hormonal therapy

  3. Duration of treatment when the toxicity happens [ Time Frame: Immediate evaluation ]
    Description of the duration of treatment when the toxicity happens (role of cumulative dose)

  4. Drug-drug interactions associated with adverse events [ Time Frame: Immediate evaluation ]
    Description of the drug-drug interactions associated with adverse events (particularly heart failure, ischemic heart disease and cardiac arrhythmia's)

  5. Pathologies for which the incriminated drugs have been prescribed [ Time Frame: Immediate evaluation ]
    Description of the pathologies (cancer, hormonal insufficiency) for which the incriminated drugs have been prescribed

  6. Population of patients having a cardio-vascular adverse event [ Time Frame: Immediate evaluation ]
    Description of the population of patients having a cardio-vascular adverse event



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population is selected in the French pharmacovigilance database and EudraCT database from 01/01/1985 to 14/04/2017 and included patients treated with hormonal therapies included in the ATC classification references: G03, H01C and L02.
Criteria

Inclusion Criteria:

  • Case reported in the French pharmacovigilance database and EudraCT database from 01/01/1985 to 14/04/2017
  • Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the HLT Death and Sudden Death
  • Patients treated with hormonal therapies included in the ATC classification references: G03, H01C and L02

Exclusion Criteria:

  • Chronology not compatible between the drug and the toxicity

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): NCT03193138


Locations
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France
Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
Paris, Ile De France, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere

Publications of Results:
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Responsible Party: Joe Elie Salem, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03193138     History of Changes
Other Study ID Numbers: CIC1421-17-06
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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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
Androgens
Hormone Replacement Therapy
Testosterone
Androgen Antagonists

Additional relevant MeSH terms:
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Heart Diseases
Cardiotoxicity
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs