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.|
|ClinicalTrials.gov 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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- all cause mortality [ Time Frame: three and half years ]
- Cardiac mortality [ Time Frame: three and half years ]
- Sudden cardiac death [ Time Frame: three and half years ]
- Worsening heart failure warranting hospitalization [ Time Frame: three and half years ]
- Need for cardiac stimulation in the ICD arm [ Time Frame: three and half years ]
- Need for pacemaker implantation in the amiodarone therapy arm [ Time Frame: three and half years ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01722942
|Contact: Martino Martinelli, MD, PhD||55 11 email@example.com|
|Contact: Sergio F Siqueira, Eng, MsC||55 11 firstname.lastname@example.org|
|Principal Investigator:||Martino Martinelli, Prof.||InCor Heart Institute|