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

NCT01722942 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2021-08-30

No results posted yet for this study

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).

Conditions

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

Interventions

PROCEDURE

ICD implantation

ventricular ICD implantation

DRUG

amiodarone hydrochloride

amiodarone prescription

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Abbott Medical Devices

    collaborator INDUSTRY

  • InCor Heart Institute

    lead OTHER

Principal Investigators

  • Martino Martinelli, Prof. · InCor Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-06
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01722942 on ClinicalTrials.gov