Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death (CHAGASICS)
This study is not yet open for participant recruitment.
Verified January 2013 by InCor Heart Institute
Sponsor:
InCor Heart Institute
Collaborators:
Ministry of Health, Brazil
St Jude Medical Brasil Ltda
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Martino Martinelli Filho, InCor Heart Institute
ClinicalTrials.gov Identifier:
NCT01722942
First received: November 1, 2012
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Chagas Cardiomyopathy Non-sustained Ventricular Tachycardia At Least 10 Points in Rassi Risk Score for Death |
Procedure: ICD implantation Drug: amiodarone hydrochloride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by InCor Heart Institute:
Primary Outcome Measures:
- all cause mortality [ Time Frame: three and half years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cardiac mortality [ Time Frame: three and half years ] [ Designated as safety issue: No ]
- Sudden cardiac death [ Time Frame: three and half years ] [ Designated as safety issue: No ]
- Worsening heart failure warranting hospitalization [ Time Frame: three and half years ] [ Designated as safety issue: No ]
- Need for cardiac stimulation in the ICD arm [ Time Frame: three and half years ] [ Designated as safety issue: No ]
- Need for pacemaker implantation in the amiodarone therapy arm [ Time Frame: three and half years ] [ Designated as safety issue: No ]
Other Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1100 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Drug: amiodarone hydrochloride |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722942
Contacts
| Contact: Martino Martinelli, MD, PhD | 55 11 26615515 | martino@incor.usp.br |
| Contact: Sergio F Siqueira, Eng, MsC | 55 11 26615514 | siqueira@incor.usp.br |
Locations
| Brazil | |
| Hospital Ana Nery | Not yet recruiting |
| Salvador, BA, Brazil | |
| Contact: Luiz P Magalhães, MD luizpmagalhaes@uol.com.br | |
| Contact: Alexandro A Fagundes, MD alexfagundes@cardiol.br | |
| Principal Investigator: Luiz P Magalhães, MD | |
| Sub-Investigator: Alexsandro A Fagundes, MD | |
| Santa Casa de Salvador | Not yet recruiting |
| Salvador, BA, Brazil | |
| Contact: Ricardo E Pereira, MD rickeloy@terra.com.br | |
| Principal Investigator: Ricardo E Pereira, MD | |
| Hospital Universitário Walter Cantideo | Not yet recruiting |
| Fortaleza, CE, Brazil | |
| Contact: Francisca TM Pereira, MD tatianap@baydenet.com.br | |
| Contact: Eduardo A Rocha, MD eduardoa@cardiol.br | |
| Principal Investigator: Francisca TM Pereira, MD | |
| Sub-Investigator: Eduardo A Rocha, MD | |
| Sub-Investigator: Marcelo P Monteiro, MD | |
| Hospital de Messejana | Not yet recruiting |
| Fortaleza, CE, Brazil | |
| Contact: João D Souza Neto, MD jdsneto@cardiol.br | |
| Contact: Stela MV Sampaio, MD stelavsampaio@terra.com.br | |
| Principal Investigator: João D Souza Neto, MD | |
| Sub-Investigator: Stela MV Sampaio, MD | |
| Instituto de Cardiologia do Distrito Federal | Not yet recruiting |
| Brasilia, DF, Brazil | |
| Contact: José M Baggio Jr, MD jmbaggio@cardiol.br | |
| Principal Investigator: José M Baggio Jr, MD | |
| Sub-Investigator: Renato Bueno, MD | |
| Hospital de Base | Not yet recruiting |
| Brasilia, DF, Brazil | |
| Contact: Ayrton K Peres, MD, PhD ayrton.ritmocardio@gmail.com | |
| Contact: Tamer N Seixas, MD, PhD tamersn@cardiol.br | |
| Principal Investigator: Ayrton K Peres, MD, PhD | |
| Sub-Investigator: Thamer N Seixas, MD, PhD | |
| Sub-Investigator: Edna MM Oliveira, MD | |
| Sub-Investigator: Marcus VN Santos, MD | |
| Sub-Investigator: Romeu Mello Neto, MD | |
| Anis Rassi Hospital | Not yet recruiting |
| Goiania, GO, Brazil | |
| Contact: Anis Rassi Jr, MD, PhD arassijr@terra.com.br | |
| Principal Investigator: Anis Rassi Jr, MD, PhD | |
| Hospital das Clínicas de Goiania | Not yet recruiting |
| Goiania, GO, Brazil | |
| Contact: Salvador Rassi, MD, PhD srassi@cardiol.br | |
| Principal Investigator: Salvador Rassi, MD, PhD | |
| Santa Casa de Goiania | Not yet recruiting |
| Goiania, GO, Brazil | |
| Contact: Sérgio Rassi, MD sgrassi@cultura.com.br | |
| Contact: Antônio MC Lima, MD antoniomalanc@gmail.com | |
| Sub-Investigator: Antonio MC Lima, MD | |
| Principal Investigator: Sérgio Rassi, MD | |
| Hospital das Clínicas da UFMG | Not yet recruiting |
| Belo Horizonte, MG, Brazil | |
| Contact: Henrique B Moureira, MD moreira@cardiol.br | |
| Contact: Antonio LP Ribeiro, MD, PhD tom@hc.ufmg.br | |
| Principal Investigator: Henrique B Moreira, MD | |
| Sub-Investigator: Antonio LP Ribeiro, MD, PhD | |
| Hospital Felício Rocho | Not yet recruiting |
| Belo Horizonte, MG, Brazil | |
| Contact: Maria CV Moreira, MD, PhD moreiram@cardiol.br | |
| Contact: Thiago R Rodrigues, MD thiagorrodrigues@oi.com.br | |
| Sub-Investigator: Thiago R Rodrigues, MD | |
| Principal Investigator: Maria CV Moreira, MD, PhD | |
| Hospital das Clínicas Samuel Libânio | Not yet recruiting |
| Pouso Alegre, MG, Brazil | |
| Contact: Ricardo A Teixeira, MD, PhD ricardo.alkmim@hotmail.com | |
| Principal Investigator: Ricardo A Teixeira, MD, PHD | |
| Hospital Escola da Universidade Federal do Triângulo Mineiro | Not yet recruiting |
| Uberaba, MG, Brazil | |
| Contact: Celso S Melo, MD celsosalgado@uol.com.br | |
| Principal Investigator: Celso S Melo, MD | |
| Hospital Geral Universitário | Not yet recruiting |
| Cuiabá, MT, Brazil | |
| Contact: Júlio C Oliveira, MD, PhD juliocesar@atriumcardiologia.com.br | |
| Principal Investigator: Júlio C Oliveira, MD, PhD | |
| Hospital Universitário Procape | Not yet recruiting |
| Recife, PE, Brazil | |
| Contact: Dário Sobral Filho, MD, PhD dsobral@uol.com.br | |
| Contact: Abelardo G Escarião, MD escariao@hotmail.com | |
| Principal Investigator: Dário C Sobral Filho, MD, PhD | |
| Sub-Investigator: Adelardo G Escariao, MD | |
| Sub-Investigator: Antonio M Nascimento, MD | |
| Sub-Investigator: Wilson A Oliveira Jr, MD | |
| Hospital Santa Casa de Misericórdia de Curitiba | Not yet recruiting |
| Curitiba, PR, Brazil | |
| Contact: Gerson Lemke, MD | |
| Contact: José CM Jorge, MD, PhD mourajorge@terra.com.br | |
| Principal Investigator: Gerson Lemke, MD | |
| Sub-Investigator: José CM Jorge, MD, PhD | |
| Hospital Universitário Onofre Lopes - UFRGN | Not yet recruiting |
| Natal, RN, Brazil | |
| Contact: Nestor R Oliveira Neto, MD nestor_rn@superig.com.br | |
| Principal Investigator: Nestor R Oliveira Neto, MD | |
| Hospital do Coração de Natal | Not yet recruiting |
| Natal, RN, Brazil | |
| Contact: Álvaro RB Costa, MD alvaro@digi.com.br | |
| Principal Investigator: Álvaro RB Costa, MD | |
| Hospital das Clínicas da UNICAMP | Not yet recruiting |
| Campinas, SP, Brazil | |
| Contact: Márcio JO Figueiredo, MD, PhD mjofig@gmail.com | |
| Principal Investigator: Márcio JO Figueiredo, MD, PhD | |
| Sub-Investigator: Otávio R Coelho, MD | |
| Hospital e Maternidade Celso Pierro - PUCC | Not yet recruiting |
| Campinas, SP, Brazil | |
| Contact: José MN Lima, MD, PhD jmarcolima@gmail.com | |
| Contact: Fernando M Porto, MD ritmocamp@hotmail.com | |
| Principal Investigator: José MN Lima, MD, PhD | |
| Sub-Investigator: Fernando M Porto, MD | |
| Sub-Investigator: Halim Cury Filho, MD | |
| Hospital do Coração da Fundação de Misericórdia de Franca | Not yet recruiting |
| Franca, SP, Brazil | |
| Contact: Rodrigo T Silva, MD, PhD rotasil@ig.com.br | |
| Principal Investigator: Rodrigo T Silva, MD, PhD | |
| Santa Casa de Ribeirão Preto | Not yet recruiting |
| Ribeirão Preto, SP, Brazil, 14080-000 | |
| Contact: Antonio Vitor Moraes Jr, MD, PhD +55 16 97920407 avitor@terra.com.br | |
| Principal Investigator: Antonio Vitor Moraes Jr, MD, PhD | |
| HC - FMUSP / Ribeirão Preto | Not yet recruiting |
| Ribeirão Preto, SP, Brazil | |
| Contact: José A Marin-Neto, MD, Full Prof. marin_neto@yahoo.com | |
| Contact: Marcelo G Leal, MD, PhD mgleal@cardiol.br | |
| Principal Investigator: José A Marin-Neto, MD, FullProf | |
| Principal Investigator: Marcelo G Leal, MD, PhD | |
| Sub-Investigator: Elerson Arfelli, MD | |
| Sub-Investigator: Andre Schmidt, MD, PhD | |
| Sub-Investigator: Adilson Escorzonic, MD | |
| Sub-Investigator: Jairo R Silva Jr, MD | |
| Sub-Investigator: Henrique T Moreira, MD | |
| Sub-Investigator: Maria LRC Pavao, MD | |
| Instituto de Moléstias Cardiovasculares | Not yet recruiting |
| São José do Rio Preto, SP, Brazil | |
| Contact: Adalberto Lorga Filho, MD, PhD lorgafilho@terra.com.br | |
| Contact: Oswaldo T Greco, MD oswaldogreco@terra.com.br | |
| Principal Investigator: Adalberto Lorga Filho, MD, PhD | |
| Sub-Investigator: Oswaldo T Greco, MD, PhD | |
| Sub-Investigator: Rinaldo Santos, MD | |
| Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Not yet recruiting |
| São Paulo, SP, Brazil, 05403000 | |
| Contact: Martino Martinelli, MD, PhD 55 11 26615515 martino@incor.usp.br | |
| Contact: Sergio F Siqueira, Eng, MsC 55 11 26615514 siqueira@incor.usp.br | |
| Sub-Investigator: Sérgio F Siqueira, Eng, MsC | |
| Sub-Investigator: Giselle L Peixoto, MD | |
| Sub-Investigator: Roberto Costa, MD, PhD | |
| Sub-Investigator: Maurício I Scanavacca, MD, PhD | |
| Sub-Investigator: Antonio CP Barreto, MD, PhD | |
| Sub-Investigator: Barbara M Ianni, MD, PhD | |
| Sub-Investigator: Denise T Hachul, MD, PhD | |
| Sub-Investigator: Edmar Bocchi, MD, PhD | |
| Sub-Investigator: Fernando Bacal, MD, PhD | |
| Sub-Investigator: Francisco CC Darriex, MD, PhD | |
| Sub-Investigator: Germano Souza, MD, PhD | |
| Sub-Investigator: Silvana AD Nishioka, MD, PhD | |
| Sub-Investigator: Anisio AA Pedrosa, MD, PhD | |
| Sub-Investigator: Ricardo A Teixeira, MD, PhD | |
| Principal Investigator: Jose Antonio Marin-Neto, Prof | |
| Principal Investigator: Anis Rassi Jr, MD, PhD | |
| Instituto Dante Pazzanese de Cardiologia | Not yet recruiting |
| São Paulo, SP, Brazil | |
| Contact: Juan C Pachón, MD juanpachon@gmail.com | |
| Principal Investigator: Juan C Pachon, MD | |
| Escola Paulista de Medicina | Not yet recruiting |
| São Paulo, SP, Brazil | |
| Contact: Angelo Paola, MD, Full Prof depaola@uol.com.br | |
| Contact: Guilherme Fenelon, MD, PhD guilhermefenelon@uol.com.br | |
| Principal Investigator: Angelo Paola, MD, Full Prof | |
| Sub-Investigator: Guilherme Fenelon, MD, PhD | |
| Irmandade da Santa Casa de Misericordia de São Paulo | Not yet recruiting |
| São Paulo, SP, Brazil | |
| Contact: Sylvio MA Gandra, MD, PhD smag01@terra.com.br | |
| Principal Investigator: Sylvio MA Gandra, MD, PhD | |
| Beneficiência Portuguesa | Not yet recruiting |
| São Paulo, SP, Brazil | |
| Contact: Silas S Galvão Filho, MD sdsantos@uol.com.br | |
| Contact: José TM Vasconcelos, MD, PhD tarr@terra.com.br | |
| Principal Investigator: Silas S Galvão Filho | |
| Sub-Investigator: José TM Vasconcelos, MD, PhD | |
Sponsors and Collaborators
InCor Heart Institute
Ministry of Health, Brazil
St Jude Medical Brasil Ltda
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
| Principal Investigator: | Martino Martinelli, Prof. | InCor Heart Institute |
More Information
No publications provided
| Responsible Party: | Martino Martinelli Filho, PhD, MD, InCor Heart Institute |
| ClinicalTrials.gov Identifier: | NCT01722942 History of Changes |
| Other Study ID Numbers: | CHAGASICS |
| Study First Received: | November 1, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by InCor Heart Institute:
|
Chagas cardiomyopathy sudden cardiac death primary prevention of death amiodarone implantable cardioverter defibrillator |
Additional relevant MeSH terms:
|
Chagas Disease Chagas Cardiomyopathy Death Tachycardia Tachycardia, Ventricular Cardiomyopathies Trypanosomiasis Euglenozoa Infections Protozoan Infections Parasitic Diseases Heart Diseases |
Cardiovascular Diseases Pathologic Processes Arrhythmias, Cardiac Amiodarone Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on May 21, 2013