MedTrace Logo

A Trial Testing Amiodarone in Chagas Cardiomiopathy

NCT03193749 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-06-21

No results posted yet for this study

Summary

Purpose:

The ATTACH trial, as currently designed, will primarily test whether a treatment with Amiodarone for at least 6 months has a trypanocidal effect among individuals with mild-to-moderate Chronic Chagas Cardiomyopathy. A secondary goal will be to confirm, in this population, a clinical benefit from this treatment (in terms of reducing mortality or cardiac arrhythmic events), and to explore whether a potential trypanocidal effect is associated with a clinical benefit.

Conditions

  • Chagas Cardiomyopathy

Interventions

DRUG

Amiodarone Hydrochloride

Starting (loading) dose 400 mg PO once a day for 10 days. Maintainance dose 200 mg PO once a day for at least 6 months, up to 24 months

DRUG

Placebo Oral Tablet

Matching placebo for tablets of 200 mg of Amiodarone

Sponsors & Collaborators

  • Instituto de Corazón de Bucaramanga

    collaborator UNKNOWN

  • Fundación Cardioinfantil Instituto de Cardiología

    lead OTHER

Principal Investigators

  • Juan C Villar, MD, MSc, PhD · Department of Research, Fundación Cardioinfantil - Instituto de Cardiología

  • Diego A Rodriguez, MD · Department of Cardiology, Fundación Cardioinfantil - Instituto de Cardiología

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • Colombia

Study Locations

More Related Trials

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 NCT03193749 on ClinicalTrials.gov