Clinical Trials Logo

Clinical Trial Summary

Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.

CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other androgen-deprivation therapies are not associated with increased mineral corticosteroid level.

This study investigates reports of cardiovascular toxicities for treatment including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate cancer in the French pharmacovigilance database and in the EudraCT database.


Clinical Trial Description

Due to its peculiar pharmacology, abiraterone is potentially associated with more cardiotoxicity as compared to other androgen-deprivation therapies. This study investigates the main characteristics of patients affected by cardiovascular side effects of which supraventricular arrhythmias (including atrial fibrillation, atrial flutter, supraventricular tachycardia), and cardiac failure imputed to drugs classified as L02, and G03 according to anatomical therapeutic chemical (ATC) classification. A causality assessment according to the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03243604
Study type Observational
Source Groupe Hospitalier Pitie-Salpetriere
Contact
Status Completed
Phase
Start date May 16, 2017
Completion date July 13, 2017

See also
  Status Clinical Trial Phase
Completed NCT03079726 - Use of Device Data to Predict Frailty in Individuals
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT05404789 - Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia N/A
Recruiting NCT04554160 - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Recruiting NCT04471584 - Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors N/A
Recruiting NCT02906189 - Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices N/A
Completed NCT02466633 - Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias N/A
Completed NCT02550340 - Munich Study for Beer Related ECG Change Workup N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Withdrawn NCT04556240 - RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
Active, not recruiting NCT05481359 - AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
Recruiting NCT05047835 - Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
Not yet recruiting NCT05957315 - Mobile Cardiac Outpatient Telemetry for Unexplained Syncope N/A
Not yet recruiting NCT05974306 - Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System N/A
Completed NCT06260670 - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation N/A
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed NCT04943354 - Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure N/A
Recruiting NCT03857711 - Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation) N/A