Chagas CardiomyopathyPhase 3ATTACHNCT03193749
A Trial Testing Amiodarone in Chagas Cardiomiopathy
A Phase 3 study testing Amiodarone Hydrochloride in people with Chagas Cardiomyopathy, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chagas Cardiomyopathy
- What is being tested?
- Amiodarone Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jun 2017to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Cardioinfantil - Instituto de Cardiología
Bogotá
Eliana Vaquiro, RN, CCRN, 6672727 ext. 73200, evaquiro@cardioinfantil.org
About this study
Official title: A Trial Testing Amiodarone in Chagas Cardiomyopathy (ATTACH)
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.
Read the 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
- Conditions
- Chagas Cardiomyopathy
- Being tested
- Amiodarone Hydrochloride, Placebo Oral Tablet
- Keywords
- Chagas disease, cardiomyopathy, amiodarone, clinical trial
- Medical subject headings
- Chagas Cardiomyopathy, Chagas Disease, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Placebo Oral TabletDrug
Matching placebo for tablets of 200 mg of Amiodarone
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone Hydrochloride | Experimental | Oral treatment for at least 6 months Receives: Drug: Amiodarone Hydrochloride |
| Placebo | Placebo comparator | Oral treatment for at least 6 months Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after starting treatment
Secondary outcomes (2)
Composite of clinical events
- All-cause deaths; b) EKG-supported ventricular tachycardia or, c) Hospitalization for cardiac causes
Measured: Up to study closure or 24 months after randomization (whichever comes first)
Elements of the composite outcome of clinical events individually
Measured: Up to study closure or 24 months after randomization (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start12 Jun 2017
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chagas CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Cardioinfantil Instituto de Cardiología
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Corazón de Bucaramanga
- Responsible party
- Sponsor
- Investigators
- Juan C Villar, MD, MSc, PhD, Principal investigator, Department of Research, Fundación Cardioinfantil - Instituto de CardiologíaDiego A Rodriguez, MD, Principal investigator, Department of Cardiology, Fundación Cardioinfantil - Instituto de Cardiología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193749
- Sponsor's protocol ID
- 880-2015
- Other IDs
- 277872553480
- Acronym
- ATTACH
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon submission of primary results, following requests of editors, by request to the steering committee
Publications
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.
PubMed 16928995Rassi 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.
PubMed 17339568Veiga-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.
PubMed 22591838Adesse 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.
PubMed 21078932Benaim 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.
PubMed 16451055
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Testing Amiodarone in Chagas Cardiomyopathy (ATTACH)
- ClinicalTrials.gov ID
- NCT03193749
- Acronym / sponsor ID
- ATTACH / 880-2015
- Conditions
- Chagas Cardiomyopathy
- Keywords
- Chagas disease, cardiomyopathy, amiodarone, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación Cardioinfantil Instituto de CardiologíaUniversity, hospital or other
- Collaborators
- Instituto de Corazón de Bucaramanga
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone Hydrochloride | Experimental | Drug: Amiodarone HydrochlorideOral treatment for at least 6 months |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletOral treatment for at least 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amiodarone HydrochlorideStarting (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 | Drug | Amiodarone Hydrochloride |
| Placebo Oral TabletMatching placebo for tablets of 200 mg of Amiodarone | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Composite of clinical events
Time frame: Up to study closure or 24 months after randomization (whichever comes first)
Elements of the composite outcome of clinical events individually
Time frame: Up to study closure or 24 months after randomization (whichever comes first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Background: PubMed 16928995Rassi 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.
- Background: PubMed 17339568Rassi 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.
- Background: PubMed 22591838Veiga-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.
- Background: PubMed 21078932Adesse 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.
- Background: PubMed 16451055Benaim 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.
- Individual participant dataSharing planned: Yes. Upon submission of primary results, following requests of editors, by request to the steering committee
Related trials for Chagas Cardiomyopathy
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Villar, MD, MSc, PhD principal investigator
Department of Research, Fundación Cardioinfantil - Instituto de Cardiología
Diego A Rodriguez, MD principal investigator
Department of Cardiology, Fundación Cardioinfantil - Instituto de Cardiología
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone Hydrochloride in people with Chagas Cardiomyopathy, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan C Villar, MD, MSc, PhD (16672727 ext. 73200, jvillarc@cardioinfantil.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive PCR for Trypanosoma cruzi (time frame: 6 months after starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193749, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.