Trial · NCT04984616
Atorvastatin on Inflammation and Cardiac Function in Chronic Chagas Disease
NCT04984616, Phase 2, Terminated, Juan D. Maya
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atorvastatin on Inflammation and Cardiac Function in Chronic Chagas Disease. Trials, record NCT04984616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04984616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atorvastatin on Inflammation and Cardiac Function in Chronic Chagas Disease
- NCT number
- NCT04984616
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 300 participants, actual
- Lead sponsor
- Juan D. Maya
- Conditions
- Chronic Chagas Disease
- Interventions
- 40 mg Atorvastatin/day for 120 days P.O., Atorvastatin 80, Placebo
- First posted
- 2021-07-30
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients that present a change in the phase of the chronic cardiomyopathy | Twelve months | To evaluate whether the effect of atorvastatin in combination with antiparasitic therapy (NFX or BZD), more effective than antiparasitic therapy alone in preventing the onset of cardiac disorders as determined by non-progression in the phase from the A-phase according to the I Latin American Guidelines for the diagnosis and treatment of Chagas cardiomyopathy (Andrade et al, Arq Bras Cardiol 2011;97 Suppl 3:1-48.). |
| Secondary | plasma levels of cytokines (pg/mL) | Twelve months | Plasma levels of the tumor necrosis factor -α, interferon -γ, IL-10, IL-1B, IL-4, and IL-17A cytokines will be determined by a multiplex analysis |
| Secondary | Plasma levels of endothelial adhesion molecules (pg/mL) | Twelve months | Plasma levels of the soluble forms of Intercellular Cell Adhesion Molecule-1, Vascular Cell Adhesion Molecule-1, and E-selectin, as determined by a multiplex analysis |
| Secondary | Proportion of patients with change in heart rate measured by electrocardiographic examination | Twelve months | Percentage of patients in the treatment arms that present changes in cardiac rate as compared with the placebo arm |
| Secondary | Proportion of patients with changes in the QT interval duration (milliseconds) | Twelve months | Percentage of patients in the treatment arms that present changes in repolarization, as determined by the QT interval duration in the electrocardiogram, when compared with the placebo arm |
| Secondary | Proportion of patients with abnormalities in ventricular electrical conduction determined by the duration of the QRS interval (milliseconds) | Twelve months | Percentage of patients in the treatment arms that present changes in ventricular conduction, as determined by QRS interval duration in the electrocardiogram, when compared with the placebo arm |
| Secondary | Proportion of patients with alterations in ventricular function as measured by changes in the ejection fraction percentage estimated by echocardiography | Twelve months | Percentage of patients in the treatment arms that present changes in ventricular function, as determined by ejection fraction calculated using echocardiography analysis, when compared with the placebo arm. |
| Secondary | Plasma levels of Cardiac function biomarkers (pg/mL) | Twelve months | Cardiac functional damage evidenced by a change in the plasma levels of brain natriuretic peptide (BNP) and cardiac troponin T (cTnT) |
| Secondary | Parasite load in a blood sample (number of parasites/mL) | Twelve months | To determine the parasitic load in blood by quantitative polymerase chain reaction assay (qPCR) |
| Secondary | Incidence of severe adverse events | Twelve months | To evaluate the incidence of treatment discontinuation due to severe Adverse Events |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36638112 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04984616
GET https://conductscience.org/api/trials/v1/NCT04984616/registered