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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.