Trial · NCT02386358
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cardiovascular Mortality | Time to event: from date of randomization until the date of first documented progression or date of death from any cause up to 10 years of follow-up | Sudden death, unexpectedly in time and in its presentation,preceded by the abrupt loss of consciousness within a maximum of one hour of the onset of symptoms,when it happened during sleep or unexpectedly in a patient was stable until then. Related Death, when presented in a patient with signs of progressive heart failure.Ischemic or Hemorrhagic Stroke |
| Primary | Development of heart failure | Time to event: from date of randomization until the date of first documented progression of heart failure up to 10 years of follow-up | Dyspnea is evaluated according to the classification of the New York Heart Association (NYHA),gallop rhythm, jugular venous distension, crackles in the lungs, edema or pleural effusion,hepatomegaly |
| Primary | Severe arrhythmias with hemodynamic compromise or pacemaker implant or Implantable cardiac defibrillator | Time to event: from date of randomization until the date of first documented progression up to 10 years of follow-up | Sustained ventricular tachycardia, atrioventricular block, trifascicular block, Atrial fibrillation |
| Secondary | Electrocardiographic endpoints. New development of permanent changes in the electrocardiographic | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | * Stable sinus bradycardia (\<50 beats / min) * Auriculoventricular blocks of 2nd and 3rd degree * Left anterior hemi-block * Complete right bundle branch block * Atrial flutter or fibrillation * Sustained ventricular tachycardia |
| Secondary | Changes in clinical stage in chronic Chagas disease | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical progression |
| Secondary | Enlargement of the left ventricle (LV) detected by echocardiography. | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical Progression |
| Secondary | New Heart Failure | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical Progression |
| Secondary | Stroke | Time to event: from date of randomization until the date of first documented as defined in the secondary outcome up to 10 years of follow-up | Clinical progression |
| Secondary | Serological negativization | time to event: from the date of randomization to the date of the first documented serological negativization that persists until 10 years of follow-up | by ELISA F29 vs. conventional serology as a late indicator of efficacy or therapeutic failure. |
| Secondary | Development and validation of RT-PCR | time to event: from the date of randomization to the date of the first documented no detectable RT-PCR that persists until 10 years of follow-up | Demonstration of RT-PCR as an early indicator of efficacy or therapeutic failure. |
| Secondary | Changes of the secondary objectives during RCT development. New single endpoints | Since October 2011 during 18 months | 1. Any change in clinical stage 0 to II due to left ventricular enlargement demonstrated by echocardiogram, or I to III stage due to development of heart failure. 2. Complete left branch block * 3\. Atrial fibrillation * 4\. Repetitive ventricular extrasystoles: doublets, triplets, bigemina, trigeminus, ventricular tachycardia |
| Secondary | Combined clinical endpoints: | Since October 2011 during 18 months | * Right bundle branch block associated with left anterior hemi-block. * Parietal motility disorders of left ventricle by echocardiography (akinesia, hypokinesia, and dyskinesia) associated with impaired left ventricular systolic function. * Parietal motility disorders of left ventricle by echocardiogram (Akinesia, Hypokinesia, dyskinesia) and /or impaired LV systolic function associated with new electrocardiographic changes (complete left branch block, right bundle branch block, left anterior hemi-block, ventricular extrasystoles. * Occurrence of left ventricle aneurysm point by echocardiogram associated to ventricular arrhythmia (section 2.4.1.4.). * Occurrence of left ventricle aneurysm point by echocardiogram associated with depression of LV systolic function by echocardiography. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02386358/registered