CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)

NCT03193138 | Completed

• 1 other identifier: CIC1421-17-06
• Study Type: observational
• Target: 3,096
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

Cardiotoxicity; Androgens; Hormone Replacement Therapy; Testosterone; Androgen Antagonists

Outcome Measures

Primary Outcomes (3)

• 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

  Immediate evaluation

• 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

  Immediate evaluation

• 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

  Immediate evaluation

Secondary Outcomes (6)

• Causality assessment of reported cardiovascular events

  Immediate evaluation

• Type of cardiotoxicity depending on the category and type of hormonal therapy

  Immediate evaluation

• Duration of treatment when the toxicity happens

  Immediate evaluation

• Drug-drug interactions associated with adverse events

  Immediate evaluation

• Pathologies for which the incriminated drugs have been prescribed

  Immediate evaluation

Interventions

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Chronology not compatible between the drug and the toxicity

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

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

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

Location

Related Publications (4)

• 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.

  PMID: 31378084 BACKGROUND

• 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.

  PMID: 29967236 RESULT

• 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.

  PMID: 30698686 RESULT

• 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.

  PMID: 32171470 DERIVED

MeSH Terms

Conditions

Heart Diseases; Cardiotoxicity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 20, 2017
• Study Start: June 7, 2017
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

FR (1)