A Trial Testing Amiodarone in Chagas Cardiomiopathy

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03193749
• Date of registration: 19/06/2017
• Prospective Registration: No
• Primary sponsor: Fundación Cardioinfantil Instituto de Cardiología
• Public title: A Trial Testing Amiodarone in Chagas Cardiomiopathy ATTACH
• Scientific title: A Trial Testing Amiodarone in Chagas Cardiomyopathy (ATTACH)
• Date of first enrolment: June 12, 2017
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03193749
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Colombia

Contacts

• Name: Juan C Villar, MD, MSc, PhD

• Name: Eliana Vaquiro, RN, CCRN

• Name: Diego A Rodriguez, MD
• Affiliation: Department of Cardiology, Fundación Cardioinfantil - Instituto de Cardiología

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chagas Cardiomyopathy

Intervention(s)

Drug: Amiodarone Hydrochloride

Drug: Placebo Oral Tablet

Primary Outcome(s)

Positive PCR for Trypanosoma cruzi [Time Frame: 6 months after starting treatment]

Secondary Outcome(s)

Elements of the composite outcome of clinical events individually [Time Frame: Up to study closure or 24 months after randomization (whichever comes first)]

Composite of clinical events [Time Frame: Up to study closure or 24 months after randomization (whichever comes first)]

Secondary ID(s)

880-2015

277872553480

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Corazón de Bucaramanga