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Heart DiseasesTORNICSNCT03193138

CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)

An observational study of Heart Diseases, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Heart Diseases
What is being tested?
Hormonal therapies: G03, H01C and L02 in the ATC classification
How many people
3,096 participants
Where
1 siteFrance
Study dates
7 Jun 2017to 21 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Chronology not compatible between the drug and the toxicity

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Paris, Île-de-France Region, 75013

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Heart Diseases
Being tested
Hormonal therapies: G03, H01C and L02 in the ATC classification
Keywords
Cardiotoxicity, Androgens, Hormone Replacement Therapy, Testosterone, Androgen Antagonists
Medical subject headings
Heart Diseases, Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hormonal therapies: G03, H01C and L02 in the ATC classificationDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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

    Measured: Immediate evaluation

  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.

    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

    Measured: Immediate evaluation

  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.

    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

    Measured: Immediate evaluation

Secondary outcomes (6)

  1. Causality assessment of reported cardiovascular events

    Causality assessment of reported cardiovascular events according to the WHO-UMC system

    Measured: Immediate evaluation

  2. Type of cardiotoxicity depending on the category and type of hormonal therapy

    Description of the type of cardiotoxicity depending on the category and type of hormonal therapy

    Measured: Immediate evaluation

  3. Duration of treatment when the toxicity happens

    Description of the duration of treatment when the toxicity happens (role of cumulative dose)

    Measured: Immediate evaluation

  4. Drug-drug interactions associated with adverse events

    Description of the drug-drug interactions associated with adverse events (particularly heart failure, ischemic heart disease and cardiac arrhythmia's)

    Measured: Immediate evaluation

  5. Pathologies for which the incriminated drugs have been prescribed

    Description of the pathologies (cancer, hormonal insufficiency) for which the incriminated drugs have been prescribed

    Measured: Immediate evaluation

  6. Population of patients having a cardio-vascular adverse event

    Description of the population of patients having a cardio-vascular adverse event

    Measured: Immediate evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2017
  2. Study start7 Jun 2017
  3. Primary completion21 Jun 2017
  4. Study completion21 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
3,096 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03193138
Sponsor's protocol ID
CIC1421-17-06
Acronym
TORNICS
Status last verified
Sep 2019
First submitted
12 Jun 2017
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Salem JE, Yang T, Moslehi JJ, Waintraub X, Gandjbakhch E, Bachelot A, Hidden-Lucet F, Hulot JS, Knollmann BC, Lebrun-Vignes B, Funck-Brentano C, Glazer AM, Roden DM. Androgenic Effects on Ventricular Repolarization: A Translational Study From the International Pharmacovigilance Database to iPSC-Cardiomyocytes. Circulation. 2019 Sep 24;140(13):1070-1080. doi: 10.1161/CIRCULATIONAHA.119.040162. Epub 2019 Aug 5.

    PubMed 31378084

  • Salem JE, Waintraub X, Courtillot C, Shaffer CM, Gandjbakhch E, Maupain C, Moslehi JJ, Badilini F, Haroche J, Gougis P, Fressart V, Glazer AM, Hidden-Lucet F, Touraine P, Lebrun-Vignes B, Roden DM, Bachelot A, Funck-Brentano C. Hypogonadism as a Reversible Cause of Torsades de Pointes in Men. Circulation. 2018 Jul 3;138(1):110-113. doi: 10.1161/CIRCULATIONAHA.118.034282. No abstract available.

    PubMed 29967236

  • Barber M, Nguyen LS, Wassermann J, Spano JP, Funck-Brentano C, Salem JE. Cardiac arrhythmia considerations of hormone cancer therapies. Cardiovasc Res. 2019 Apr 15;115(5):878-894. doi: 10.1093/cvr/cvz020.

    PubMed 30698686

  • Salem JE, Yang T, Moslehi JJ, Waintraub X, Gandjbakhch E, Bachelot A, Hidden-Lucet F, Hulot JS, Knollmann BC, Lebrun-Vignes B, Funck-Brentano C, Glazer AM, Roden DM. Androgenic effects on ventricular repolarization: A translational study from the international pharmacovigilance database to iPSC-cardiomyocytes. Ann Endocrinol (Paris). 2021 Jun;82(3-4):132-133. doi: 10.1016/j.ando.2020.02.008. Epub 2020 Feb 29.

    PubMed 32171470

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Diseases, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03193138, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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