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Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death (CHAGASICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01722942
Recruitment Status : Unknown
Verified September 2014 by Martino Martinelli Filho, InCor Heart Institute.
Recruitment status was:  Not yet recruiting
First Posted : November 7, 2012
Last Update Posted : September 9, 2014
Ministry of Health, Brazil
Abbott Medical Devices
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Martino Martinelli Filho, InCor Heart Institute

Brief 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).

Condition or disease Intervention/treatment Phase
Chagas Cardiomyopathy Non-sustained Ventricular Tachycardia At Least 10 Points in Rassi Risk Score for Death Procedure: ICD implantation Drug: amiodarone hydrochloride Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHronic Use of Amiodarone aGAinSt Implantable Cardioverter-defibrillator Therapy for Primary Prevention of Death in Patients With Chagas Cardiomyopathy Study (CHAGASICS)
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Active Comparator: 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.
Procedure: ICD implantation
ventricular ICD implantation

Active Comparator: 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.
Drug: amiodarone hydrochloride

Primary Outcome Measures :
  1. all cause mortality [ Time Frame: three and half years ]

Secondary Outcome Measures :
  1. Cardiac mortality [ Time Frame: three and half years ]
  2. Sudden cardiac death [ Time Frame: three and half years ]
  3. Worsening heart failure warranting hospitalization [ Time Frame: three and half years ]
  4. Need for cardiac stimulation in the ICD arm [ Time Frame: three and half years ]
  5. Need for pacemaker implantation in the amiodarone therapy arm [ Time Frame: three and half years ]

Other Outcome Measures:
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01722942

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Contact: Martino Martinelli, MD, PhD 55 11 26615515
Contact: Sergio F Siqueira, Eng, MsC 55 11 26615514

Show Show 27 study locations
Sponsors and Collaborators
InCor Heart Institute
Ministry of Health, Brazil
Abbott Medical Devices
Fundação de Amparo à Pesquisa do Estado de São Paulo
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Principal Investigator: Martino Martinelli, Prof. InCor Heart Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Martino Martinelli Filho, PhD, MD, InCor Heart Institute Identifier: NCT01722942    
Other Study ID Numbers: CHAGASICS
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014
Keywords provided by Martino Martinelli Filho, InCor Heart Institute:
Chagas cardiomyopathy
sudden cardiac death
primary prevention of death
implantable cardioverter defibrillator
Additional relevant MeSH terms:
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Chagas Cardiomyopathy
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Chagas Disease
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors