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Chagas DiseasePhase 4NCT01539161

Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease

A Phase 4 study testing Implantable Cardiac Monitor in people with Chagas Disease and Heart Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study "Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients with Chagas Disease" is a prospective, multicenter, randomized study that is being conducted at several centers in Latin America with commercially available products. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chagas Disease, Heart Diseases
What is being tested?
Implantable Cardiac Monitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesin 2 countries
Study dates
Jul 2013to Apr 2015
Phase
Phase 4
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have Chagas disease, confirmed by two serological tests.
  • Provide evidence through any of the following diagnosis methods: Rest ECG, 24 hour Holter monitoring, electrophysiological study, stress test or loop monitoring, at least one electrical disorder consistent with sinus bradycardia greater than 45 and lower than 60 bpm, sinus arrest not greater than 2.0 seconds, second degree atrial sinus block, intraventricular conduction disorders such as right branch, left branch or a bifascicular blockage type, first degree A-V blockage, or of type I second degree AV Block without associated bradycardia, atrial and/or ventricular arrhythmias that do NOT constitute an indication for pacemaker implant, ICD or mapping and radio frequency ablation.
  • Be asymptomatic or having minimal isolated unspecific symptoms not consistent with cardiac arrest, aborted sudden death, syncope, frequent and recurrent palpitations, cardiac failure, and lower extremity edema.
  • Have ejection fraction of left ventricle >35%
  • Be able to give his/her written informed consent.
  • Subject should be > 21 years old.
  • Be able to return for follow-up visits as required.

Who cannot join

  • Class I or II (according to AHA/HRS/ESC guidelines) indication for final implantation of pacemaker, ICD, or cardiac resynchronizer.
  • Exhibit extrinsic causes of sinus dysfunction or A-V blockage.
  • Exhibit infiltrative myocardial diseases such as tumors or associated valvular defects.
  • Suffer any concurrent disease that may limit the follow up or evaluation.
  • Suffer aftereffects of cerebral embolism.
  • Suffer ablation or isolation of pulmonary veins previous to their inclusion in the study.
Show all 17Show fewer
  • Not being able or willing to comply with the follow-up schedule.
  • Have previous lesions of the spinal cord or aftereffects of skull trauma.
  • Have a record of epilepsy.
  • Receive pharmacological treatment for other diseases that may modify the autonomic function.
  • Have a record of myocardial infarction.
  • History of alcohol abuse or drug addiction.
  • History of emotional instability, unstable psychiatric disorders or are under treatment for such disorders.
  • Have previously implanted pacemakers, cardiodefibrillators or CRT systems.
  • Are included or intend to participate in another study of devices during the course of this study.
  • Have a clinical condition that may limit life expectancy to < 36 months.
  • Use of Antiarrhythmic drugs, except Beta Blockers

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Argentina2 sites

  • Hospital General de Agudos "Juan Fernandez"

    Buenos Aires, Buenos Aires F.D.

  • Hospital Interzonal General de Agudos "General José de San Martin"

    La Plata

Other trials in Argentina

Colombia2 sites

  • Fundacion Cardioinfantil

    Bogotá

  • Hospital Militar Central

    Bogotá

Other trials in Colombia

About this study

The study "Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients with Chagas Disease" is a prospective, multicenter, randomized study that is being conducted at several centers in Latin America with commercially available products.

The primary study hypothesis is that patients with implantable cardiac monitors will have a shorter time to the decision to treat for electrical or arrhythmic disorders during the follow-up period.

The geography includes Argentina and Colombia.

Read the detailed description

The purpose is to study the possible benefit of a superior treatment decision rate for cardiac arrhythmias (brady- and or/ tachyarrhythmias) using an implantable cardiac monitor (ICM) in patients with Chagas Disease diagnosed by serology, who are asymptomatic and/or minimally symptomatic. Patients that meet inclusion criteria of the study will be randomized to standard care or standard care plus ICM.

Approximately half of the patients will receive an ICM. All patients will be followed for 36 months. It is expected that the enrollment phase will last 1 year, and that the total study duration will be 4 years. The study is expected to end in 2017. One hundred and two patients are needed for 95% confidence level and 80% statistical power to be randomized into the study, at approximately 5 centers in Latin America. Patients will be considered enrolled once they have signed the Informed Consent. The following additional parameters will also be collected:

  • Recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia)
  • Time duration spent in arrhythmia and incidence of symptomatic arrhythmias in patients with an ICM.
  • Clinical data on subject outcomes and changes in heart failure as assessed by heart failure hospitalizations, New York Heart Association class and mortality.
Being tested
Implantable Cardiac Monitor, Standard of Care
Keywords
Chagas Disease, Chagasic, Reveal XT, Implantable Cardiac Monitor, ICM
Medical subject headings
Chagas Disease, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable Cardiac MonitorDevice

    Also called 9529 Reveal XT, 9539 Reveal XT Patient Assistant

    9529 Reveal XT Implantable Cardiac Monitor as well as the use of 9539 Reveal XT Patient Assistant.

  • Standard of CareProcedure or surgery

    Also called SOC

    Standard of care arm including exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months.

Study groups in NCT01539161
Study groupRoleWhat they receive
Reveal XT plus SOCExperimentalStandard of care treatment plus the Reveal XT Implantable Cardiac Monitor. Treatment will follow the same schedule of the standard of care arm regarding exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months. The addition will be device interrogation at every 6 month exam. Participation will last 36 months.
Receives: Device: Implantable Cardiac Monitor
Standard of CareActive comparatorStandard of care arm as described by exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months. Participation will last 36 months.
Receives: Procedure: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the time to the physician's decision to treat for electrical disorders (brady/tachyarrhythmias) between the two randomized groups.

    The primary endpoint is time to the first decision to implant a device (IPG, CRT-P, ICD or CRT-D) or prescribe anti-arrhythmic drugs.

    Measured: 36 months

Secondary outcomes (5)

  1. Summarize the recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia.

    Compute summary statistics for arrhythmic events recorded during follow-up, whether or not related to symptoms, for all patients in the ICM arm, including the total number, distribution (e.g., minimum, maximum, median, quartiles, and standard deviation), number per patient year, number of patients having events and percentage of patients having events. Summary statistics for bradyarrhythmia and tachyarrhythmia events will also be computed separately.

    Measured: 36 months

  2. Compute the time duration spent in arrhythmias for ICM patients.

    Compute the total duration each ICM patient spends in, 1) atrial arrhythmias and 2) ventricular arrhythmias during the entire follow-up period, and their corresponding distribution (e.g., minimum, maximum, median, quartiles, standard deviation). Compute the average duration each patient spends in an, 1) atrial arrhythmia event, and 2) a ventricular arrhythmia event, and the corresponding distributions.

    Measured: 36 months

  3. Compute the incidence of symptomatic arrhythmias in patients with an ICM

    Compute the incidence rate of symptomatic arrhythmias in patients with an ICM, overall, and for bradyarrhythmias and tachyarrhythmias separately.

    Measured: 36 months

  4. Compare the time to the physician's decision to treat with components of the composite primary endpoint between randomization arms.

    Individually compare the time to the physicians' decision to treat with the following between the two randomization arms:

    • A device of any type (IPG, CRT-P, ICD or CRT-D)
    • A pacemaker (IPG)
    • Anti-arrhythmic drug therapy
    • A defibrillator (ICD or CRT-D) or prescribe anti-arrhythmic drug therapy

    Measured: 36 months

  5. Compare the mortality rate between randomization arms.

    Compare the mortality rate between randomization arms.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2012 (estimated)
  2. Study startJul 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Why it stopped: Extremely low enrollment rate

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01539161
Sponsor's protocol ID
Reveal Chagas
Status last verified
Oct 2016
First submitted
9 Feb 2012
Last updated
12 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Implantable Cardiac Monitor in people with Chagas Disease and Heart Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in 2 countries.

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 7 inclusion and 17 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: stopped early, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Argentina, 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Extremely low enrollment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the time to the physician's decision to treat for electrical disorders (brady/tachyarrhythmias) between the two randomized groups. (time frame: 36 months). 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 NCT01539161.

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 12 Oct 2016.

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