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NCT Number: NCT03193138

CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)

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.

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Key information

Conditions

Heart Diseases Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière

Paris, Île-de-France Region, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hormonal therapies: G03, H01C and L02 in the ATC classification

Drug

Hormonal therapies including all therapies classified G03, H01C and L02 in the ATC classification

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Cardiotoxicity of Androgenic Agonists and Antagonists in the National French Pharmacovigilance Database and EudraCT Database

Acronym: TORNICS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2017
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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