Chagas Cardiomyopathy | Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death
Chagas Cardiomyopathy research study
What is the primary objective of this study?
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 is eligible to participate?
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-menopausal patients who have not undergone a safe and permanent birth control method); - Other contraindications for the use of amiodarone: previous intolerance to the drug; HR < 55bpm; sinus node disease; type II Mobitz; fixed 2:1 AV block; advanced degree atrioventricular block (AV) block; Complete AV block; QTc > 500mseg; - Formal indication for the use of amiodarone or defibrillator (NSVT and very disturbing palpitations, presyncope or syncope; SVT; recovery from cardiac arrest); - Use of amiodarone in the past 6 months, except if started for < 2 weeks and if loading dose had been <10g and maintenance dose ≤100mg/day; - Current use of betablocker considered clinically indispensable, with bradycardia < 55/min or AV block ≥ 1st degree, without pacemaker implantation; - Current use of other medications with contraindication to the concomitant use of amiodarone; - Persistent or permanent atrial fibrillation; - Previous withdrawal from this study.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Non-sustained Ventricular Tachycardia
At Least 10 Points in Rassi Risk Score for Death
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:ICD implantationventricular ICD implantation
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ICD groupICD implantation will be performed according to the Institution protocol of each participating center; single-chamber devices are preferred and programming should prioritize the patient's own pace, avoiding ventricular stimulation.
Amiodarone GroupPatients randomized for this group will receive amiodarone hydrochloride (once a day) according to the following regimen: Initial oral loading dose of 600 mg/day for 10 days on an outpatient basis; After the loading period, an oral dose between 200 and 400 mg/day should be maintained until study termination. The determination of the optimal maintenance dose will be left at the discretion of each investigator; this dose may be based on the therapeutic response on 24-hour Holter monitoring, resting heart rate (HR), side effects, prolonged corrected QT interval (QTc), etc. Dose adjustments will be allowed throughout the study period provided the maintenance dose is kept between 200 and 400 mg/day. If the patient cannot tolerate the minimum 200 mg/day dose, amiodarone should be discontinued permanently and treatment should be considered interrupted.
Not yet recruiting
Start Date: October 2014
Completed Date: October 2019
Primary Outcome: all cause mortality
Secondary Outcome: Cardiac mortality
Study sponsors, principal investigator, and references
Principal Investigator: Martino Martinelli, Prof.
Lead Sponsor: InCor Heart Institute
Collaborator: Ministry of Health, Brazil