Heart and Blood Diseases

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Heart Failure

Prostatic Neoplasms

Atrial Fibrillation

Arrhythmias, Cardiac

Cardiotoxicity

Tachycardia

Tachycardia, Supraventricular

Heart Diseases

Cardiac Conduction System Disease

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Hormones

Abiraterone Acetate

Androgen Antagonists

Hormone Antagonists

Androgen-deprivation therapies including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones)

L02 (sex hormones used in treatment of neoplastic diseases) and G03 (sex hormones)

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.

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.

cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study

Cardiotoxicity of Abiraterone in the National French Pharmacovigilance Database and in the European Clinical Trials Database (EudraCT)

Analysis of disproportionality of reports for cardiotoxicity associated with abiraterone as compared to enzalutamide by performing a case- non-case study

Compare the reporting of suspected drug-induced supraventricular arrhythmias with abiraterone as compared to enzalutamide by performing a disproportionality analysis

Compare the reporting of drug-induced cardiac failure with abiraterone as compared to enzalutamide by performing a disproportionality analysis

Compare the reporting of drug-induced cardiac failure and/or supraventricular arrhythmias with abiraterone as compared to other androgen-deprivation therapies by performing a disproportionality analysis

Description of other mineralocorticoid related adverse events (hypokaliemia, fluid retention, and hypertension) when the cardio toxicity occurs

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

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

Description of the drug-drug interactions associated with adverse events

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

Groupe Hospitalier Pitie-Salpetriere

MD, PhD

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Myocardial Infarction

Infarction

Stroke

Ischemic Stroke

Ischemia

Endocarditis

Foramen Ovale, Patent

Embolic Stroke

Heart Neoplasms

Cerebral Infarction

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Necrosis

Coronary Artery Disease

Myocardial Ischemia

Brain Infarction

Brain Ischemia

Heart Septal Defects

Heart Septal Defects, Atrial

Heart Defects, Congenital

Congenital Abnormalities

Cardiovascular Abnormalities

Thoracic Neoplasms

Heart Tumor

Natriuretic Agents

Natriuretic Peptide, Brain

N,N-dimethylarginine

Enzyme Inhibitors

Patients with stroke of undetermined cause age 18-65

ADMA, NTproBNP, IL-6, Adiponectina, Leptine, Syndecan, Resistin

ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin

A stroke is the second cause of deaths after heart attack, one of the most important causes of malfunction as far as adults are concerned and the second as for the frequency cause of dementia. In spite of a possibility of the therapy of stroke ( tissue plasminogen activator) and recognized most of risk factors there is expected that incidence rate on stroke connected with ageing of the society will be growing. It will cause medical and social consequences.

There are many of potential causes of cardiac strokes, which are not entirely examined.

More over many cryptogenic strokes are presumed to have an embolic etiology, and the frequent cause of these kind of strokes at young age is probably the mechanism of paradoxical embolism through patent foramen ovale.

As far as the investigators are concerned, at present there is lack of any recommendations for these scientific hypothesis.

A stroke is the second cause of deaths after heart attack, one of the most important causes of malfunction as far as adults are concerned and the second as for the frequency cause of dementia. In spite of a possibility of the therapy of stroke ( tissue plasminogen activator) and recognized most of risk factors there is expected that incidence rate on stroke connected with ageing of the society will be growing. It will cause medical and social consequences.

The risk factors of stroke can be divided into alterable and not alterable. Importantly, the not alterable factors are: age, sex, race and genetic factors. After the age of 55 the risk of stroke grows twice in every decade of life. Moreover, it was alleged that incidence rate on stroke is more frequent at women than at men. At the black race the incidence rate on stroke is twice more frequent than at white race.

Well- known are also genetic syndromes connected with strokes like s. MELAS or CADASIL.

Well- known alterable factors are:

* hypertension
* coronary disease
* atrial fibrillation
* hypercholesterolemia
* diabetes
* nicotinism
* blood clotting disorder
* alcoholism
* TIA (transient ischemic attack) or previous former stroke
* asymptomatic stenosis of internal carotid artery

Cardiogenic stroke is a stroke caused by embolic material, which was created in cardiac cavities or on cardiac valves. They comprised 11% of all strokes and 25% of ischemic strokes. Additionally, among patients over 80 years old cardiac causes are responsible for even 40% of all ischemic strokes and half of cardiogenic strokes is caused of atrial fibrillation. Among young people (below 45 years old) about 50% of strokes are cardiogenic and are connected with paradoxical embolism at patients with patent foramen ovale.

Furthermore, cardiac- brain embolism is a result of:

* structural defect of cavities and valves of heart
* arrhythmia
* disturbances of movability of walls of the heart and function of endocardium which leads to increased risk of the risk of parietal thrombus
* cardiac insufficiency

There are many of potential causes of cardiac strokes, which are not entirely examined as for example:

* small pockets of intra- atrial septum
* structures in dextral atrium like Eustachian valve or Chiari network
* there is also a theory that even enlargement of left atrium may be the cause of brain stroke
* aneurysm of intra- atrial septum.

As far as the investigators are concerned, at present there is lack of any recommendations for these scientific hypothesis.

Available data suggest that in the comparison with atherosclerosis and lacunar strokes cardiogenic strokes characterize with high mortality ranging of 27%. Also the risk of relapse is higher than in strokes of other etiology.

Nevertheless, unfortunately, in spite of wide diagnostics at about 25-30% of patients with ischemic stroke the cause is unknown. This kind of stroke is called cryptogenic stroke or stroke with undefined etiology.

They constitute almost half of all ischemic stroke at young patients (below 55 years old). Many cryptogenic strokes are presumed to have an embolic etiology, and the frequent cause of these kind of strokes at young age is probably the mechanism of paradoxical embolism through patent foramen ovale.

To conclude, currently there aren't researches defining recommendations for long- lasting treatment patients with rare causes of strokes.

Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis

NTproB (N-terminal pro b-type natriuretic peptide)

Medical University of Lodz

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study	NCT03243604	Arrhythmias, Ca... Atrial Fibrilla... Tachycardia, Su... Cardiac Failure	L02 (sex hormon...	18 Years -	Groupe Hospitalier Pitie-Salpetriere
Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis	NCT03377465	Embolic Stroke ... Ischemic Stroke Atrial Fibrilla... Myocardial Infa... Cardiac Tumor Endocarditis Patent Foramen ...	ADMA (asymmetri...	18 Years - 65 Years	Medical University of Lodz
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study	NCT03243604	Arrhythmias, Ca... Atrial Fibrilla... Tachycardia, Su... Cardiac Failure	L02 (sex hormon...	18 Years -	Groupe Hospitalier Pitie-Salpetriere
Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis	NCT03377465	Embolic Stroke ... Ischemic Stroke Atrial Fibrilla... Myocardial Infa... Cardiac Tumor Endocarditis Patent Foramen ...	ADMA (asymmetri...	18 Years - 65 Years	Medical University of Lodz

Spots Global Cancer Trial Database for atrial fibrillation and flutter