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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Matching placebo|
|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|
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
- 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
- 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
- Elements of the composite outcome of clinical events individually [ Time Frame: Up to study closure or 24 months after randomization (whichever comes first) ]
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
|Contact: Juan C Villar, MD, MSc, PhD||16672727 ext email@example.com|
|Contact: Eliana Vaquiro, RN, CCRN||16672727 ext firstname.lastname@example.org|
|Fundación Cardioinfantil - Instituto de Cardiología||Recruiting|
|Contact: Eliana Vaquiro, RN, CCRN 6672727 ext 73200 email@example.com|
|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|