A Trial Testing Amiodarone in Chagas Cardiomiopathy

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Cardioinfantil Instituto de Cardiología
• Collaborator: Instituto de Corazón de Bucaramanga
• Treatments: Amiodarone

Criteria

ATTACH will enroll individuals with positive serology for Trypanozoma cruzi and evidence of both structrural and rythm/conduction cardiac abnormalities, as defined by any of the following inclusion criteria

1. Structural cardiac abnormality (at least one):

• NTpro-BNP values >125 ng/ml, or BNP values > 50 ng/ml

• Left ventricular ejection fraction (LVEF) <50% or left diastolic diameter > 5.5 cm

• Symptoms of heart failure, or one episode of acute heart failure over the last 12 months

2. Rrythm/conduction cardiac abnormality (at least one)

• EKG monitoring showing 10 or more VPBs/hour or ventricular Tachycardia

• EKG showing left anterior hemiblockade or right bundle branch blocakde

• Use of a cardiac stimulation device as treatment for A-V block or Sinus node dysfunction

The protocol allows concurrent treatments for the condition (e.g. beta-blockers, ACE inhibitors, etc.) other than Amiodarone. Individuals meeting the above eligibility criteria who have previously received trypanocidal therapy (e.g. Benznidazole or Nifurtimox) can still be included, as long as they prove to be PCR positive for T. cruzi at enrollment. Co-intervention with these agents during the study will also be allowed, as per physician's judgment, either as open label treatment, or as part of another study not involving Amiodarone.

Exclusion criteria:

• LVEF < 30% or NYHA Class III-IV

• Medical prescription with chronic use of Amiodarone

• Pregancy (currently, or planned in the following 2 years), or childbearing age without reliable birth control

• Heart rate < 50 or AV blockade without treatment with cardiac stimulation device

• Contraindication for Amiodarone as per treating physician (e.g. because of long QT syndrome, thyroid disease, interstitial lung disease)

• Atrial fibrillation