A Trial Testing Amiodarone in Chagas Cardiomiopathy

Phase 3

• Conditions: Chagas Cardiomyopathy
• Interventions: Drug: Placebo Oral Tablet; Drug: Amiodarone Hydrochloride

• Registration Number: NCT03193749
• Lead Sponsor: Fundación Cardioinfantil Instituto de Cardiología

Brief 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.

Detailed Description

Investigators currently plan to enroll over 200 participants in Bogotá and Bucaramanga, Colombia. Such sample size will provide 82% of statistical power to detect at least a 30% relative reduction in the primary outcome. This is assuming that at least 75% of untreated participants will test positive at least once after three qualitative PCR assays for Trypanosoma cruzi during the 6th month after randomization (allowing for up to 10% losses to follow up and treatment adherence over 90%).

ATTACH is currently seeking collaborating centers internationally. The current funding structure will allow to test study hypothesis on trypanocidal effect, whereas data on clinical effects will be exploratory. Investigators expect to increase the sample size to at least 600 participants in order to a) enhance geographical variability/generalizability for the primary results and b) to achieve enough statistical power to test the hypothesis on clinical impact.

New centers are welcome to join this protocol, either as a placebo-controlled or as a pragmatic, open label trial. These centers will be working with the central coordination with their own funding/logistic capabilities. In the open label protocol, eligible, consenting participants will be randomly prescribed or not to Amiodarone. As assessing clinical impact will be the priority, new centers are not required to have on-site PCR capabilities. These centers are encouraged to store blood samples for PCR testing elsewhere later, if possible.

See details on eligibility, interventions and outcome measures below

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06-12
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Last Update Submitted: 2017-06-20
• Study First Posted: 2017-06-21
• Last Update Posted: 2017-06-21
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	Oral treatment for at least 6 months
Amiodarone Hydrochloride	Amiodarone Hydrochloride	Oral treatment for at least 6 months

Primary Outcome Measures

Name	Time	Method
Positive PCR for Trypanosoma cruzi	6 months after starting treatment	Conventional (qualitative) Polymerase Chain Reaction. At least one positive result out of three tests at least one week apart from each other

Secondary Outcome Measures

Name	Time	Method
Composite of clinical events	Up to study closure or 24 months after randomization (whichever comes first)	a) All-cause deaths; b) EKG-supported ventricular tachycardia or, c) Hospitalization for cardiac causes
Elements of the composite outcome of clinical events individually	Up to study closure or 24 months after randomization (whichever comes first)

Trial Locations

Locations (1)

Fundación Cardioinfantil - Instituto de Cardiología; 🇨🇴 Bogotá, Colombia