<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01722942</url>
  </required_header>
  <id_info>
    <org_study_id>CHAGASICS</org_study_id>
    <nct_id>NCT01722942</nct_id>
  </id_info>
  <brief_title>Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death</brief_title>
  <acronym>CHAGASICS</acronym>
  <official_title>CHronic Use of Amiodarone aGAinSt Implantable Cardioverter-defibrillator Therapy for Primary Prevention of Death in Patients With Chagas Cardiomyopathy Study (CHAGASICS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InCor Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>InCor Heart Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to compare the efficacy of the treatment using implantable&#xD;
      cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in&#xD;
      the primary prevention of all-cause mortality in high-risk patients with Chagas&#xD;
      cardiomyopathy and non-sustained ventricular tachycardia (NSVT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chagas disease is an endemic problem in Latin America, where millions of people are&#xD;
      chronically infected by Trypanosoma cruzi. The disease has also recently become clinically&#xD;
      and epidemiologically relevant in several other countries due to social factors related to&#xD;
      individuals migration and globalization. Chagas cardiomyopathy occurs in 30%-50% of the&#xD;
      infected individuals, leading to considerable morbidity and mortality rates. Sudden cardiac&#xD;
      death is the major cause of death in patients with Chagas cardiomyopathy. While implantable&#xD;
      cardioverter defibrillator and treatment with amiodarone have been recommended and performed&#xD;
      empirically for the secondary prevention in patients with Chagas cardiomyopathy, no&#xD;
      consistent scientific evidence exists on the role of these therapeutic strategies for the&#xD;
      primary prevention of Sudden cardiac death in patients with Chagas cardiomyopathy and high&#xD;
      mortality risk.&#xD;
&#xD;
      The main hypothesis of this study is that implantable cardioverter defibrillator implantation&#xD;
      is more efficient in the primary prevention of death in Chagas cardiomyopathy than drug&#xD;
      therapy with amiodarone in patients with documented non-sustained ventricular tachycardia.&#xD;
&#xD;
      We should point out that the death risk will be assessed using the Rassi risk score for death&#xD;
      prediction validated based on non-invasive variables and, depending on the results of this&#xD;
      study, it may guide the indication of implantable cardioverter defibrillator in Chagas&#xD;
      cardiomyopathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 6, 2014</start_date>
  <completion_date type="Anticipated">July 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>all cause mortality</measure>
    <time_frame>three and half years</time_frame>
    <description>All cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac mortality</measure>
    <time_frame>three and half years</time_frame>
    <description>cardiac mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sudden cardiac death</measure>
    <time_frame>three and half years</time_frame>
    <description>Sudden cardiac death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsening heart failure warranting hospitalization</measure>
    <time_frame>three and half years</time_frame>
    <description>Worsening heart failure warranting hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for cardiac stimulation in the ICD arm</measure>
    <time_frame>three and half years</time_frame>
    <description>Need for cardiac stimulation in the ICD arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for pacemaker implantation in the amiodarone therapy arm</measure>
    <time_frame>three and half years</time_frame>
    <description>Need for pacemaker implantation in the amiodarone therapy arm</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subgroup analyses will include gender, age ≥ or &lt; 60 years, occurrence or not of atrial fibrillation, New York Heart Association (NYHA) functional class I and II versus III and IV, as well as Rassi score points.</measure>
    <time_frame>three and half years</time_frame>
    <description>Subgroup analyses will include gender, age ≥ or &lt; 60 years, occurrence or not of atrial</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1100</enrollment>
  <condition>Chagas Cardiomyopathy</condition>
  <condition>Non-sustained Ventricular Tachycardia</condition>
  <condition>At Least 10 Points in Rassi Risk Score for Death</condition>
  <arm_group>
    <arm_group_label>ICD group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amiodarone Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized for this group will receive amiodarone hydrochloride (once a day) according to the following regimen:&#xD;
Initial oral loading dose of 600 mg/day for 10 days on an outpatient basis;&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ICD implantation</intervention_name>
    <description>ventricular ICD implantation</description>
    <arm_group_label>ICD group</arm_group_label>
    <other_name>ICD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>amiodarone hydrochloride</intervention_name>
    <description>amiodarone prescription</description>
    <arm_group_label>Amiodarone Group</arm_group_label>
    <other_name>amiodarone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent prior to randomization and any study procedure;&#xD;
&#xD;
          -  Both genders, age &gt; 18 years and &lt; 75 years;&#xD;
&#xD;
          -  Recent (previous 6 months) documented positive serologic test for Chagas disease in at&#xD;
             least two different tests (indirect hemagglutination, indirect immunofluorescence, or&#xD;
             ELISA);&#xD;
&#xD;
          -  Presence of at least 10 points in Rassi risk score for death prediction;&#xD;
&#xD;
          -  Presence of at least 1 episode of NSVT on Holter monitoring, defined as &gt; 3 successive&#xD;
             beats and duration &lt; 30 seconds, with HR &gt; 120 bpm is mandatory.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another study currently or &lt; 1 year ago, except for totally unrelated&#xD;
             observational studies;&#xD;
&#xD;
          -  Other concomitant cardiovascular disease, including uncontrolled diabetes mellitus&#xD;
             (systemic hypertension without target-organ impairment is allowed);&#xD;
&#xD;
          -  Renal dysfunction (serum creatinine &gt; 1.5 mg/dL or glomerular filtration rate (GFR) &lt;&#xD;
             60 mL/min/1.73m2) or liver dysfunction with diagnosis of cirrhosis or portal&#xD;
             hypertension or elevated serum enzymes (AST or ALT) &gt; 3 x the upper normal limit;&#xD;
&#xD;
          -  Moderate or severe chronic obstructive pulmonary disease;&#xD;
&#xD;
          -  Peripheral polyneuropathy;&#xD;
&#xD;
          -  Hypo or hyper-thyroidism;&#xD;
&#xD;
          -  Current alcoholism or quit for &lt;2 years;&#xD;
&#xD;
          -  Mental disorder or illicit drug addiction;&#xD;
&#xD;
          -  Life expectancy &lt; 1 year, because of the disease itself or of comorbidities (including&#xD;
             NYHA class IV CHF);&#xD;
&#xD;
          -  Pregnancy or breastfeeding;&#xD;
&#xD;
          -  Childbearing potential during the study (non-menopausal patients who have not&#xD;
             undergone a safe and permanent birth control method);&#xD;
&#xD;
          -  Other contraindications for the use of amiodarone: previous intolerance to the drug;&#xD;
             HR &lt; 55bpm; sinus node disease; type II Mobitz; fixed 2:1 AV block; advanced degree&#xD;
             atrioventricular block (AV) block; Complete AV block; QTc &gt; 500mseg;&#xD;
&#xD;
          -  Formal indication for the use of amiodarone or defibrillator (NSVT and very disturbing&#xD;
             palpitations, presyncope or syncope; SVT; recovery from cardiac arrest);&#xD;
&#xD;
          -  Use of amiodarone in the past 6 months, except if started for &lt; 2 weeks and if loading&#xD;
             dose had been &lt;10g and maintenance dose ≤100mg/day;&#xD;
&#xD;
          -  Current use of betablocker considered clinically indispensable, with bradycardia &lt;&#xD;
             55/min or AV block ≥ 1st degree, without pacemaker implantation;&#xD;
&#xD;
          -  Current use of other medications with contraindication to the concomitant use of&#xD;
             amiodarone;&#xD;
&#xD;
          -  Persistent or permanent atrial fibrillation;&#xD;
&#xD;
          -  Previous withdrawal from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martino Martinelli, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>InCor Heart Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martino Martinelli, MD, PhD</last_name>
    <phone>55 11 26615515</phone>
    <email>martino@incor.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sergio F Siqueira, Eng, MsC</last_name>
    <phone>55 11 26615514</phone>
    <email>siqueira@incor.usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Ana Nery</name>
      <address>
        <city>Salvador</city>
        <state>BA</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Luiz P Magalhães, MD</last_name>
      <email>luizpmagalhaes@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Alexandro A Fagundes, MD</last_name>
      <email>alexfagundes@cardiol.br</email>
    </contact_backup>
    <investigator>
      <last_name>Luiz P Magalhães, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexsandro A Fagundes, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Walter Cantideo</name>
      <address>
        <city>Fortaleza</city>
        <state>CE</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francisca TM Pereira, MD</last_name>
      <email>tatianap@baydenet.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Eduardo A Rocha, MD</last_name>
      <email>eduardoa@cardiol.br</email>
    </contact_backup>
    <investigator>
      <last_name>Francisca TM Pereira, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eduardo A Rocha, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcelo P Monteiro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Instituto de Cardiologia do Distrito Federal</name>
      <address>
        <city>Brasilia</city>
        <state>DF</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José M Baggio Jr, MD</last_name>
      <email>jmbaggio@cardiol.br</email>
    </contact>
    <investigator>
      <last_name>José M Baggio Jr, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Renato Bueno, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Anis Rassi Hospital</name>
      <address>
        <city>Goiania</city>
        <state>GO</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anis Rassi Jr, MD, PhD</last_name>
      <email>arassijr@terra.com.br</email>
    </contact>
    <investigator>
      <last_name>Anis Rassi Jr, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas de Goiania</name>
      <address>
        <city>Goiania</city>
        <state>GO</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salvador Rassi, MD, PhD</last_name>
      <email>srassi@cardiol.br</email>
    </contact>
    <investigator>
      <last_name>Salvador Rassi, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Goiania</name>
      <address>
        <city>Goiania</city>
        <state>GO</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sérgio Rassi, MD</last_name>
      <email>sgrassi@cultura.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Antônio MC Lima, MD</last_name>
      <email>antoniomalanc@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Antonio MC Lima, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sérgio Rassi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Felício Rocho</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maria CV Moreira, MD, PhD</last_name>
      <email>moreiram@cardiol.br</email>
    </contact>
    <contact_backup>
      <last_name>Thiago R Rodrigues, MD</last_name>
      <email>thiagorrodrigues@oi.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Thiago R Rodrigues, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria CV Moreira, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas Samuel Libânio</name>
      <address>
        <city>Pouso Alegre</city>
        <state>MG</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ricardo A Teixeira, MD, PhD</last_name>
      <email>ricardo.alkmim@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Ricardo A Teixeira, MD, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Escola da Universidade Federal do Triângulo Mineiro</name>
      <address>
        <city>Uberaba</city>
        <state>MG</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Celso S Melo, MD</last_name>
      <email>celsosalgado@uol.com.br</email>
    </contact>
    <investigator>
      <last_name>Celso S Melo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Geral Universitário</name>
      <address>
        <city>Cuiabá</city>
        <state>Mount</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Júlio C Oliveira, MD, PhD</last_name>
      <email>juliocesar@atriumcardiologia.com.br</email>
    </contact>
    <investigator>
      <last_name>Júlio C Oliveira, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Procape</name>
      <address>
        <city>Recife</city>
        <state>PE</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dário Sobral Filho, MD, PhD</last_name>
      <email>dsobral@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Abelardo G Escarião, MD</last_name>
      <email>escariao@hotmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Dário C Sobral Filho, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adelardo G Escariao, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonio M Nascimento, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wilson A Oliveira Jr, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Casa de Misericórdia de Curitiba</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gerson Lemke, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>José CM Jorge, MD, PhD</last_name>
      <email>mourajorge@terra.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Gerson Lemke, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>José CM Jorge, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da UNICAMP</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Márcio JO Figueiredo, MD, PhD</last_name>
      <email>mjofig@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Márcio JO Figueiredo, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Otávio R Coelho, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Ribeirão Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>SP</state>
        <zip>14080-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Antonio Vitor Moraes Jr, MD, PhD</last_name>
      <phone>+55 16 97920407</phone>
      <email>avitor@terra.com.br</email>
    </contact>
    <investigator>
      <last_name>Antonio Vitor Moraes Jr, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HC - FMUSP / Ribeirão Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José A Marin-Neto, MD, FullProf</last_name>
      <email>marin_neto@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Marcelo G Leal, MD, PhD</last_name>
      <email>mgleal@cardiol.br</email>
    </contact_backup>
    <investigator>
      <last_name>José A Marin-Neto, MD, FullProf</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcelo G Leal, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elerson Arfelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andre Schmidt, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adilson Escorzonic, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jairo R Silva Jr, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henrique T Moreira, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria LC Pavao, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Instituto de Moléstias Cardiovasculares</name>
      <address>
        <city>São José do Rio Preto</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adalberto Lorga Filho, MD, PhD</last_name>
      <email>lorgafilho@terra.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Oswaldo T Greco, MD</last_name>
      <email>oswaldogreco@terra.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Adalberto Lorga Filho, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rinaldo Santos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martino Martinelli, MD, PhD</last_name>
      <phone>55 11 26615515</phone>
      <email>martino@incor.usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Sergio F Siqueira, Eng, MsC</last_name>
      <phone>55 11 26615514</phone>
      <email>siqueira@incor.usp.br</email>
    </contact_backup>
    <investigator>
      <last_name>Sérgio F Siqueira, Eng, MsC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giselle L Peixoto, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto Costa, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maurício I Scanavacca, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Barbara M Ianni, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edmar Bocchi, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fernando Bacal, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francisco CC Darriex, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Silvana AD Nishioka, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anisio AA Pedrosa, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ricardo A Teixeira, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jose Antonio Marin-Neto, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beneficiência Portuguesa</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Silas S Galvão Filho, MD</last_name>
      <email>sdsantos@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>José TM Vasconcelos, MD, PhD</last_name>
      <email>tarr@terra.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Silas S Galvão Filho</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>José TM Vasconcelos, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Escola Paulista de Medicina</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angelo Paola, MD, FullProf</last_name>
      <email>depaola@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Guilherme Fenelon, MD, PhD</last_name>
      <email>guilhermefenelon@uol.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Angelo Paola, MD, FullProf</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guilherme Fenelon, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Instituto Dante Pazzanese de Cardiologia</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paulo TJ Medeiros, MD</last_name>
      <phone>+5511996462424</phone>
      <email>paulo.medeiros@dantepazzanese.org.br</email>
    </contact>
    <investigator>
      <last_name>Paulo TJ Medeiros, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>InCor Heart Institute</investigator_affiliation>
    <investigator_full_name>Martino Martinelli Filho</investigator_full_name>
    <investigator_title>PhD, MD</investigator_title>
  </responsible_party>
  <keyword>Chagas cardiomyopathy</keyword>
  <keyword>sudden cardiac death</keyword>
  <keyword>primary prevention of death</keyword>
  <keyword>amiodarone</keyword>
  <keyword>implantable cardioverter defibrillator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chagas Cardiomyopathy</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amiodarone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01722942
org study id: CHAGASICS
nct id: NCT01722942
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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).
Chagas disease is an endemic problem in Latin America, where millions of people are
      chronically infected by Trypanosoma cruzi. The disease has also recently become clinically
      and epidemiologically relevant in several other countries due to social factors related to
      individuals migration and globalization. Chagas cardiomyopathy occurs in 30%-50% of the
      infected individuals, leading to considerable morbidity and mortality rates. Sudden cardiac
      death is the major cause of death in patients with Chagas cardiomyopathy. While implantable
      cardioverter defibrillator and treatment with amiodarone have been recommended and performed
      empirically for the secondary prevention in patients with Chagas cardiomyopathy, no
      consistent scientific evidence exists on the role of these therapeutic strategies for the
      primary prevention of Sudden cardiac death in patients with Chagas cardiomyopathy and high
      mortality risk.

      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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: all cause mortality
time frame: three and half years
description: All cause mortality
measure: Cardiac mortality
time frame: three and half years
description: cardiac mortality
measure: Sudden cardiac death
time frame: three and half years
description: Sudden cardiac death
measure: Worsening heart failure warranting hospitalization
time frame: three and half years
description: Worsening heart failure warranting hospitalization
measure: Need for cardiac stimulation in the ICD arm
time frame: three and half years
description: Need for cardiac stimulation in the ICD arm
measure: Need for pacemaker implantation in the amiodarone therapy arm
time frame: three and half years
description: Need for pacemaker implantation in the amiodarone therapy arm
measure: Subgroup analyses will include gender, age ≥ or < 60 years, occurrence or not of atrial fibrillation, New York Heart Association (NYHA) functional class I and II versus III and IV, as well as Rassi score points.
time frame: three and half years
description: Subgroup analyses will include gender, age ≥ or < 60 years, occurrence or not of atrial
arm group label: ICD group
arm group type: Active Comparator
description: 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.
arm group label: Amiodarone Group
arm group type: Active Comparator
description: 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.
intervention type: Procedure
intervention name: ICD implantation
description: ventricular ICD implantation
arm group label: ICD group
other name: ICD
intervention type: Drug
intervention name: amiodarone hydrochloride
description: amiodarone prescription
arm group label: Amiodarone Group
other name: amiodarone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Martino Martinelli, Prof.
role: Principal Investigator
affiliation: InCor Heart Institute
last name: Martino Martinelli, MD, PhD
phone: 55 11 26615515
email: martino@incor.usp.br
last name: Sergio F Siqueira, Eng, MsC
phone: 55 11 26615514
email: siqueira@incor.usp.br
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: InCor Heart Institute
investigator full name: Martino Martinelli Filho
investigator title: PhD, MD
mesh term: Chagas Cardiomyopathy
mesh term: Cardiomyopathies
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
mesh term: Death
mesh term: Amiodarone