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A Trial Testing Amiodarone in Chagas Cardiomiopathy (ATTACH)

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ClinicalTrials.gov Identifier: NCT03193749
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Instituto de Corazón de Bucaramanga
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chagas Cardiomyopathy Drug: Amiodarone Hydrochloride Drug: Placebo Oral Tablet Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matching placebo
Primary Purpose: Treatment
Official Title: A Trial Testing Amiodarone in Chagas Cardiomyopathy (ATTACH)
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: Amiodarone Hydrochloride
Oral treatment for at least 6 months
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

Placebo Comparator: Placebo
Oral treatment for at least 6 months
Drug: Placebo Oral Tablet
Matching placebo for tablets of 200 mg of Amiodarone




Primary Outcome Measures :
  1. Positive PCR for Trypanosoma cruzi [ Time Frame: 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 :
  1. Composite of clinical events [ Time Frame: 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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193749


Contacts
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Contact: Juan C Villar, MD, MSc, PhD 16672727 ext 73200 jvillarc@cardioinfantil.org
Contact: Eliana Vaquiro, RN, CCRN 16672727 ext 73200 evaquiro@cardioinfantil.org

Locations
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Colombia
Fundación Cardioinfantil - Instituto de Cardiología Recruiting
Bogotá, Colombia
Contact: Eliana Vaquiro, RN, CCRN    6672727 ext 73200    evaquiro@cardioinfantil.org   
Sponsors and Collaborators
Fundación Cardioinfantil Instituto de Cardiología
Instituto de Corazón de Bucaramanga
Investigators
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Principal Investigator: Juan C Villar, MD, MSc, PhD Department of Research, Fundación Cardioinfantil - Instituto de Cardiología
Principal Investigator: Diego A Rodriguez, MD Department of Cardiology, Fundación Cardioinfantil - Instituto de Cardiología

Publications:
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Responsible Party: Fundación Cardioinfantil Instituto de Cardiología
ClinicalTrials.gov Identifier: NCT03193749     History of Changes
Other Study ID Numbers: 880-2015
277872553480 ( Other Grant/Funding Number: Colciencias )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon submission of primary results, following requests of editors, by request to the steering committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Fundación Cardioinfantil Instituto de Cardiología:
Chagas disease, cardiomyopathy, amiodarone, clinical trial

Additional relevant MeSH terms:
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Cardiomyopathies
Chagas Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors