Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death (NCT01722942) | Clinical Trial Compass
UnknownNot Applicable
Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death
Brazil1,100 participantsStarted 2014-10-06
Plain-language summary
The primary objective is to compare the efficacy of the treatment using implantable cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in the primary prevention of all-cause mortality in high-risk patients with Chagas cardiomyopathy and non-sustained ventricular tachycardia (NSVT).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent prior to randomization and any study procedure;
* Both genders, age \> 18 years and \< 75 years;
* Recent (previous 6 months) documented positive serologic test for Chagas disease in at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA);
* Presence of at least 10 points in Rassi risk score for death prediction;
* Presence of at least 1 episode of NSVT on Holter monitoring, defined as \> 3 successive beats and duration \< 30 seconds, with HR \> 120 bpm is mandatory.
Exclusion Criteria:
* Participation in another study currently or \< 1 year ago, except for totally unrelated observational studies;
* Other concomitant cardiovascular disease, including uncontrolled diabetes mellitus (systemic hypertension without target-organ impairment is allowed);
* Renal dysfunction (serum creatinine \> 1.5 mg/dL or glomerular filtration rate (GFR) \< 60 mL/min/1.73m2) or liver dysfunction with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) \> 3 x the upper normal limit;
* Moderate or severe chronic obstructive pulmonary disease;
* Peripheral polyneuropathy;
* Hypo or hyper-thyroidism;
* Current alcoholism or quit for \<2 years;
* Mental disorder or illicit drug addiction;
* Life expectancy \< 1 year, because of the disease itself or of comorbidities (including NYHA class IV CHF);
* Pregnancy or breastfeeding;
* Childbearing potential during the study (non-menopausa…