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New treatment option for Chagas Cardiomyopathy
Official title Cardiac Contractility Modulation in Chagas Heart Disease
ClinicalTrials.gov ID: NCT05519046
What this study is testing
- What it's testing
- Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signing of an informed consent form (ICF) before randomization and any study procedure,
- Both genders, age \>18 years and \<75 years,
- Recent positive (last two years) and documented serology for Chagas disease, in at least two different tests (indirect hemagglutination, indirect...
- NYHA II-III heart failure functional class,
- LVEF\< 35%,
You likely can't join if
- Participation in another study, presently or terminated \<1 year ago, except for a totally unrelated observational study,
- Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ...
- Kidney dysfunction (serum creatinine \>1.5mg/dL or eGFR \ 3x the upper limit of normality,
- Moderate or severe chronic obstructive pulmonary disease,
- Peripheral polyneuropathy,
- Hyperthyroidism,
See the full eligibility criteria
- Signing of an informed consent form (ICF) before randomization and any study procedure,
- Both genders, age \>18 years and \<75 years,
- Recent positive (last two years) and documented serology for Chagas disease, in at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA),
- NYHA II-III heart failure functional class,
- LVEF\< 35%,
- Non left bundle branch block
- Intraventricular desynchrony (Yu index)
- Global longitudinal strain \>11 %.
- Participation in another study, presently or terminated \<1 year ago, except for a totally unrelated observational study,
- Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ compromise),
- Kidney dysfunction (serum creatinine \>1.5mg/dL or eGFR \ 3x the upper limit of normality,
- Moderate or severe chronic obstructive pulmonary disease,
- Peripheral polyneuropathy,
- Hyperthyroidism,
- Current alcoholism or not abandoned for \>2 years,
- Diagnosed with psychopathy or psychosis or addiction to illicit drugs,
- Life expectancy \<1 year, due to the disease itself or comorbidities (including NYHA class IV),
- Pregnancy or breastfeeding,
- Potential to become pregnant during the study (non-menopausal patients who have not undergone a radical and safe contraceptive process),
- Previously withdrawn from this study.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.