Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death
NCT ID: NCT01722942
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1100 participants
INTERVENTIONAL
2014-10-06
2022-07-31
Brief Summary
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Detailed Description
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The main hypothesis of this study is that implantable cardioverter defibrillator implantation is more efficient in the primary prevention of death in Chagas cardiomyopathy than drug therapy with amiodarone in patients with documented non-sustained ventricular tachycardia.
We should point out that the death risk will be assessed using the Rassi risk score for death prediction validated based on non-invasive variables and, depending on the results of this study, it may guide the indication of implantable cardioverter defibrillator in Chagas cardiomyopathy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ICD group
ICD 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.
ICD implantation
ventricular ICD implantation
Amiodarone Group
Patients 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.
amiodarone hydrochloride
amiodarone prescription
Interventions
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ICD implantation
ventricular ICD implantation
amiodarone hydrochloride
amiodarone prescription
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
Abbott Medical Devices
INDUSTRY
InCor Heart Institute
OTHER
Responsible Party
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Martino Martinelli Filho
PhD, MD
Principal Investigators
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Martino Martinelli, Prof.
Role: PRINCIPAL_INVESTIGATOR
InCor Heart Institute
Locations
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Hospital Universitário Walter Cantideo
Fortaleza, Ceará, Brazil
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
Instituto de Cardiologia do Distrito Federal
Brasília, Federal District, Brazil
Anis Rassi Hospital
Goiânia, Goiás, Brazil
Hospital das Clínicas de Goiania
Goiânia, Goiás, Brazil
Santa Casa de Goiania
Goiânia, Goiás, Brazil
Hospital Felício Rocho
Belo Horizonte, Minas Gerais, Brazil
Hospital das Clínicas Samuel Libânio
Pouso Alegre, Minas Gerais, Brazil
Hospital Escola da Universidade Federal do Triângulo Mineiro
Uberaba, Minas Gerais, Brazil
Hospital Geral Universitário
Cuiabá, Mount, Brazil
Hospital Santa Casa de Misericórdia de Curitiba
Curitiba, Paraná, Brazil
Hospital Universitário Procape
Recife, Pernambuco, Brazil
Hospital das Clínicas da UNICAMP
Campinas, São Paulo, Brazil
Santa Casa de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
HC - FMUSP / Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Instituto de Moléstias Cardiovasculares
São José do Rio Preto, São Paulo, Brazil
Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Beneficiência Portuguesa
São Paulo, São Paulo, Brazil
Escola Paulista de Medicina
São Paulo, São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Gerson Lemke, MD
Role: primary
References
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Martinelli-Filho M, Marin-Neto JA, Scanavacca MI, de Paola AAV, Medeiros PTJ, Owen R, Pocock SJ, de Siqueira SF; CHAGASICS investigators. Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy: The CHAGASICS Randomized Clinical Trial. JAMA Cardiol. 2024 Dec 1;9(12):1073-1081. doi: 10.1001/jamacardio.2024.3169.
Martinelli M, Rassi A Jr, Marin-Neto JA, de Paola AA, Berwanger O, Scanavacca MI, Kalil R, de Siqueira SF. CHronic use of Amiodarone aGAinSt Implantable cardioverter-defibrillator therapy for primary prevention of death in patients with Chagas cardiomyopathy Study: rationale and design of a randomized clinical trial. Am Heart J. 2013 Dec;166(6):976-982.e4. doi: 10.1016/j.ahj.2013.08.027. Epub 2013 Oct 11.
Other Identifiers
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CHAGASICS
Identifier Type: -
Identifier Source: org_study_id
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