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

Primary Purpose

Chagas Cardiomyopathy, Non-sustained Ventricular Tachycardia, At Least 10 Points in Rassi Risk Score for Death

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

ICD implantation

amiodarone hydrochloride

About this trial

This is an interventional treatment trial for Chagas Cardiomyopathy focused on measuring Chagas cardiomyopathy, sudden cardiac death, primary prevention of death, amiodarone, implantable cardioverter defibrillator

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Ana Nery
Hospital Universitário Walter CantideoRecruiting
Instituto de Cardiologia do Distrito FederalRecruiting
Anis Rassi Hospital
Hospital das Clínicas de GoianiaRecruiting
Santa Casa de Goiania
Hospital Felício Rocho
Hospital das Clínicas Samuel Libânio
Hospital Escola da Universidade Federal do Triângulo Mineiro
Hospital Geral Universitário
Hospital Universitário Procape
Hospital Santa Casa de Misericórdia de Curitiba
Hospital das Clínicas da UNICAMP
Santa Casa de Ribeirão Preto
HC - FMUSP / Ribeirão PretoRecruiting
Instituto de Moléstias CardiovascularesRecruiting
Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloRecruiting
Beneficiência Portuguesa
Escola Paulista de MedicinaRecruiting
Instituto Dante Pazzanese de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ICD group

Amiodarone Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

all cause mortality

All cause mortality

Secondary Outcome Measures

Cardiac mortality

cardiac mortality

Sudden cardiac death

Worsening heart failure warranting hospitalization

Need for cardiac stimulation in the ICD arm

Need for pacemaker implantation in the amiodarone therapy arm

Full Information

NCT ID

NCT01722942

First Posted

November 1, 2012

Last Updated

August 24, 2021

Sponsor

InCor Heart Institute

Collaborators

Ministry of Health, Brazil, Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT01722942

Brief Title

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

Acronym

CHAGASICS

Official Title

CHronic Use of Amiodarone aGAinSt Implantable Cardioverter-defibrillator Therapy for Primary Prevention of Death in Patients With Chagas Cardiomyopathy Study (CHAGASICS)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 6, 2014 (Actual)

Primary Completion Date

July 31, 2022 (Anticipated)

Study Completion Date

July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

InCor Heart Institute

Collaborators

Ministry of Health, Brazil, Abbott Medical Devices

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chagas Cardiomyopathy, Non-sustained Ventricular Tachycardia, At Least 10 Points in Rassi Risk Score for Death

Keywords

Chagas cardiomyopathy, sudden cardiac death, primary prevention of death, amiodarone, implantable cardioverter defibrillator

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ICD group

Arm Type

Active Comparator

Arm Description

Arm Title

Amiodarone Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

ICD implantation

Other Intervention Name(s)

ICD

Intervention Description

ventricular ICD implantation

Intervention Type

Drug

Intervention Name(s)

amiodarone hydrochloride

Other Intervention Name(s)

amiodarone

Intervention Description

amiodarone prescription

Primary Outcome Measure Information:

Title

all cause mortality

Description

All cause mortality

Time Frame

three and half years

Secondary Outcome Measure Information:

Title

Cardiac mortality

Description

cardiac mortality

Time Frame

three and half years

Title

Sudden cardiac death

Description

Sudden cardiac death

Time Frame

three and half years

Title

Worsening heart failure warranting hospitalization

Description

Worsening heart failure warranting hospitalization

Time Frame

three and half years

Title

Need for cardiac stimulation in the ICD arm

Description

Need for cardiac stimulation in the ICD arm

Time Frame

three and half years

Title

Need for pacemaker implantation in the amiodarone therapy arm

Description

Need for pacemaker implantation in the amiodarone therapy arm

Time Frame

three and half years

Other Pre-specified Outcome Measures:

Title

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.

Description

Subgroup analyses will include gender, age ≥ or < 60 years, occurrence or not of atrial

Time Frame

three and half years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martino Martinelli, MD, PhD

Phone

55 11 26615515

martino@incor.usp.br

First Name & Middle Initial & Last Name or Official Title & Degree

Sergio F Siqueira, Eng, MsC

Phone

55 11 26615514

siqueira@incor.usp.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martino Martinelli, Prof.

Organizational Affiliation

InCor Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Ana Nery

City

Salvador

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luiz P Magalhães, MD

luizpmagalhaes@uol.com.br

First Name & Middle Initial & Last Name & Degree

Alexandro A Fagundes, MD

alexfagundes@cardiol.br

First Name & Middle Initial & Last Name & Degree

Luiz P Magalhães, MD

First Name & Middle Initial & Last Name & Degree

Alexsandro A Fagundes, MD

Facility Name

Hospital Universitário Walter Cantideo

City

Fortaleza

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisca TM Pereira, MD

tatianap@baydenet.com.br

First Name & Middle Initial & Last Name & Degree

Eduardo A Rocha, MD

eduardoa@cardiol.br

First Name & Middle Initial & Last Name & Degree

Francisca TM Pereira, MD

First Name & Middle Initial & Last Name & Degree

Eduardo A Rocha, MD

First Name & Middle Initial & Last Name & Degree

Marcelo P Monteiro, MD

Facility Name

Instituto de Cardiologia do Distrito Federal

City

Brasilia

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José M Baggio Jr, MD

jmbaggio@cardiol.br

First Name & Middle Initial & Last Name & Degree

José M Baggio Jr, MD

First Name & Middle Initial & Last Name & Degree

Renato Bueno, MD

Facility Name

Anis Rassi Hospital

City

Goiania

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anis Rassi Jr, MD, PhD

arassijr@terra.com.br

First Name & Middle Initial & Last Name & Degree

Anis Rassi Jr, MD, PhD

Facility Name

Hospital das Clínicas de Goiania

City

Goiania

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Salvador Rassi, MD, PhD

srassi@cardiol.br

First Name & Middle Initial & Last Name & Degree

Salvador Rassi, MD, PhD

Facility Name

Santa Casa de Goiania

City

Goiania

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sérgio Rassi, MD

sgrassi@cultura.com.br

First Name & Middle Initial & Last Name & Degree

Antônio MC Lima, MD

antoniomalanc@gmail.com

First Name & Middle Initial & Last Name & Degree

Antonio MC Lima, MD

First Name & Middle Initial & Last Name & Degree

Sérgio Rassi, MD

Facility Name

Hospital Felício Rocho

City

Belo Horizonte

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria CV Moreira, MD, PhD

moreiram@cardiol.br

First Name & Middle Initial & Last Name & Degree

Thiago R Rodrigues, MD

thiagorrodrigues@oi.com.br

First Name & Middle Initial & Last Name & Degree

Thiago R Rodrigues, MD

First Name & Middle Initial & Last Name & Degree

Maria CV Moreira, MD, PhD

Facility Name

Hospital das Clínicas Samuel Libânio

City

Pouso Alegre

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ricardo A Teixeira, MD, PhD

ricardo.alkmim@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ricardo A Teixeira, MD, PHD

Facility Name

Hospital Escola da Universidade Federal do Triângulo Mineiro

City

Uberaba

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Celso S Melo, MD

celsosalgado@uol.com.br

First Name & Middle Initial & Last Name & Degree

Celso S Melo, MD

Facility Name

Hospital Geral Universitário

City

Cuiabá

State/Province

Mount

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Júlio C Oliveira, MD, PhD

juliocesar@atriumcardiologia.com.br

First Name & Middle Initial & Last Name & Degree

Júlio C Oliveira, MD, PhD

Facility Name

Hospital Universitário Procape

City

Recife

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dário Sobral Filho, MD, PhD

dsobral@uol.com.br

First Name & Middle Initial & Last Name & Degree

Abelardo G Escarião, MD

escariao@hotmail.com

First Name & Middle Initial & Last Name & Degree

Dário C Sobral Filho, MD, PhD

First Name & Middle Initial & Last Name & Degree

Adelardo G Escariao, MD

First Name & Middle Initial & Last Name & Degree

Antonio M Nascimento, MD

First Name & Middle Initial & Last Name & Degree

Wilson A Oliveira Jr, MD

Facility Name

Hospital Santa Casa de Misericórdia de Curitiba

City

Curitiba

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerson Lemke, MD

First Name & Middle Initial & Last Name & Degree

José CM Jorge, MD, PhD

mourajorge@terra.com.br

First Name & Middle Initial & Last Name & Degree

Gerson Lemke, MD

First Name & Middle Initial & Last Name & Degree

José CM Jorge, MD, PhD

Facility Name

Hospital das Clínicas da UNICAMP

City

Campinas

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Márcio JO Figueiredo, MD, PhD

mjofig@gmail.com

First Name & Middle Initial & Last Name & Degree

Márcio JO Figueiredo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Otávio R Coelho, MD

Facility Name

Santa Casa de Ribeirão Preto

City

Ribeirão Preto

State/Province

ZIP/Postal Code

14080-000

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio Vitor Moraes Jr, MD, PhD

Phone

+55 16 97920407

avitor@terra.com.br

First Name & Middle Initial & Last Name & Degree

Antonio Vitor Moraes Jr, MD, PhD

Facility Name

HC - FMUSP / Ribeirão Preto

City

Ribeirão Preto

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José A Marin-Neto, MD, FullProf

marin_neto@yahoo.com

First Name & Middle Initial & Last Name & Degree

Marcelo G Leal, MD, PhD

mgleal@cardiol.br

First Name & Middle Initial & Last Name & Degree

José A Marin-Neto, MD, FullProf

First Name & Middle Initial & Last Name & Degree

Marcelo G Leal, MD, PhD

First Name & Middle Initial & Last Name & Degree

Elerson Arfelli, MD

First Name & Middle Initial & Last Name & Degree

Andre Schmidt, MD, PhD

First Name & Middle Initial & Last Name & Degree

Adilson Escorzonic, MD

First Name & Middle Initial & Last Name & Degree

Jairo R Silva Jr, MD

First Name & Middle Initial & Last Name & Degree

Henrique T Moreira, MD

First Name & Middle Initial & Last Name & Degree

Maria LC Pavao, MD

Facility Name

Instituto de Moléstias Cardiovasculares

City

São José do Rio Preto

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adalberto Lorga Filho, MD, PhD

lorgafilho@terra.com.br

First Name & Middle Initial & Last Name & Degree

Oswaldo T Greco, MD

oswaldogreco@terra.com.br

First Name & Middle Initial & Last Name & Degree

Adalberto Lorga Filho, MD, PhD

First Name & Middle Initial & Last Name & Degree

Rinaldo Santos, MD

Facility Name

Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

City

São Paulo

State/Province

ZIP/Postal Code

05403000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martino Martinelli, MD, PhD

Phone

55 11 26615515

martino@incor.usp.br

First Name & Middle Initial & Last Name & Degree

Sergio F Siqueira, Eng, MsC

Phone

55 11 26615514

siqueira@incor.usp.br

First Name & Middle Initial & Last Name & Degree

Sérgio F Siqueira, Eng, MsC

First Name & Middle Initial & Last Name & Degree

Giselle L Peixoto, MD

First Name & Middle Initial & Last Name & Degree

Roberto Costa, MD, PhD

First Name & Middle Initial & Last Name & Degree

Maurício I Scanavacca, MD, PhD

First Name & Middle Initial & Last Name & Degree

Barbara M Ianni, MD, PhD

First Name & Middle Initial & Last Name & Degree

Edmar Bocchi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Fernando Bacal, MD, PhD

First Name & Middle Initial & Last Name & Degree

Francisco CC Darriex, MD, PhD

First Name & Middle Initial & Last Name & Degree

Silvana AD Nishioka, MD, PhD

First Name & Middle Initial & Last Name & Degree

Anisio AA Pedrosa, MD, PhD

First Name & Middle Initial & Last Name & Degree

Ricardo A Teixeira, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jose Antonio Marin-Neto, Prof

Facility Name

Beneficiência Portuguesa

City

São Paulo

State/Province

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Silas S Galvão Filho, MD

sdsantos@uol.com.br

First Name & Middle Initial & Last Name & Degree

José TM Vasconcelos, MD, PhD

tarr@terra.com.br

First Name & Middle Initial & Last Name & Degree

Silas S Galvão Filho

First Name & Middle Initial & Last Name & Degree

José TM Vasconcelos, MD, PhD

Facility Name

Escola Paulista de Medicina

City

São Paulo

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angelo Paola, MD, FullProf

depaola@uol.com.br

First Name & Middle Initial & Last Name & Degree

Guilherme Fenelon, MD, PhD

guilhermefenelon@uol.com.br

First Name & Middle Initial & Last Name & Degree

Angelo Paola, MD, FullProf

First Name & Middle Initial & Last Name & Degree

Guilherme Fenelon, MD, PhD

Facility Name

Instituto Dante Pazzanese de Cardiologia

City

São Paulo

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paulo TJ Medeiros, MD

Phone

+5511996462424

paulo.medeiros@dantepazzanese.org.br

First Name & Middle Initial & Last Name & Degree

Paulo TJ Medeiros, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24268211

Citation

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.

Results Reference

derived

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

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