NCT03193749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

June 19, 2017

Last Update Submit

June 20, 2017

Conditions

Chagas Cardiomyopathy

Keywords

Chagas disease, cardiomyopathy, amiodarone, clinical trial

Outcome Measures

Primary Outcomes (1)

  • Positive PCR for Trypanosoma cruzi

    Conventional (qualitative) Polymerase Chain Reaction. At least one positive result out of three tests at least one week apart from each other

    6 months after starting treatment

Secondary Outcomes (2)

  • Composite of clinical events

    Up to study closure or 24 months after randomization (whichever comes first)

  • Elements of the composite outcome of clinical events individually

    Up to study closure or 24 months after randomization (whichever comes first)

Study Arms (2)

Amiodarone Hydrochloride

EXPERIMENTAL

Oral treatment for at least 6 months

Drug: Amiodarone Hydrochloride

Placebo

PLACEBO COMPARATOR

Oral treatment for at least 6 months

Drug: Placebo Oral Tablet

Interventions

Amiodarone HydrochlorideDRUG

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

Amiodarone Hydrochloride
Placebo Oral TabletDRUG

Matching placebo for tablets of 200 mg of Amiodarone

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Cardioinfantil - Instituto de Cardiología

Bogotá, Colombia

RECRUITING

Related Publications (5)

  • Rassi A Jr, Rassi A, Little WC, Xavier SS, Rassi SG, Rassi AG, Rassi GG, Hasslocher-Moreno A, Sousa AS, Scanavacca MI. Development and validation of a risk score for predicting death in Chagas' heart disease. N Engl J Med. 2006 Aug 24;355(8):799-808. doi: 10.1056/NEJMoa053241.

    PMID: 16928995BACKGROUND

  • Rassi A Jr, Rassi A, Rassi SG. Predictors of mortality in chronic Chagas disease: a systematic review of observational studies. Circulation. 2007 Mar 6;115(9):1101-8. doi: 10.1161/CIRCULATIONAHA.106.627265.

    PMID: 17339568BACKGROUND

  • Veiga-Santos P, Barrias ES, Santos JF, de Barros Moreira TL, de Carvalho TM, Urbina JA, de Souza W. Effects of amiodarone and posaconazole on the growth and ultrastructure of Trypanosoma cruzi. Int J Antimicrob Agents. 2012 Jul;40(1):61-71. doi: 10.1016/j.ijantimicag.2012.03.009. Epub 2012 May 14.

    PMID: 22591838BACKGROUND

  • Adesse D, Azzam EM, Meirelles Mde N, Urbina JA, Garzoni LR. Amiodarone inhibits Trypanosoma cruzi infection and promotes cardiac cell recovery with gap junction and cytoskeleton reassembly in vitro. Antimicrob Agents Chemother. 2011 Jan;55(1):203-10. doi: 10.1128/AAC.01129-10. Epub 2010 Nov 15.

    PMID: 21078932BACKGROUND

  • Benaim G, Sanders JM, Garcia-Marchan Y, Colina C, Lira R, Caldera AR, Payares G, Sanoja C, Burgos JM, Leon-Rossell A, Concepcion JL, Schijman AG, Levin M, Oldfield E, Urbina JA. Amiodarone has intrinsic anti-Trypanosoma cruzi activity and acts synergistically with posaconazole. J Med Chem. 2006 Feb 9;49(3):892-9. doi: 10.1021/jm050691f.

    PMID: 16451055BACKGROUND

MeSH Terms

Conditions

Chagas CardiomyopathyChagas DiseaseCardiomyopathies

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan C Villar, MD, MSc, PhD

CONTACT

16672727jvillarc@cardioinfantil.org

Eliana Vaquiro, RN, CCRN

CONTACT

16672727evaquiro@cardioinfantil.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Matching placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

June 12, 2017

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Upon submission of primary results, following requests of editors, by request to the steering committee

Locations

CO(1)