drugset / Trial / NCT01722942
Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death
Unknown
1100 enrolled
InCor Heart Institute
Abbott Medical Devices · collabMinistry of Health, Brazil · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2014-10-06
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
Publications
- Martinelli-Filho M, Marin-Neto JA, Scanavacca MI, de Paola AAV, Medeiros PTJ, Owen R, Pocock SJ, de Siqueira SF; CHAGASICS investigators. Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy: The CHAGASICS Randomized Clinical Trial. JAMA Cardiol. 2024 Dec 1;9(12):1073-1081. doi: 10.1001/jamacardio.2024.3169.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amiodarone | Small molecule | 200 mg | Oral |
| Comparator | Amiodarone | Small molecule | 400 mg | Oral |