Improving heart function in patients with Chagas disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of cardiac contractility modulation (CCM) as an adjuvant treatment for heart failure in patients suffering from chronic Chagas cardiomyopathy (CCC). It aims to compare the clinical and functional responses of patients receiving CCM device implantation against those undergoing cardiac resynchronization therapy (CRT). The study focuses on individuals with advanced heart failure, severe systolic dysfunction, and specific conduction patterns, utilizing a randomized approach to assess outcomes. The research is particularly relevant given the high prevalence of Chagas disease in Latin America and its emerging significance in other regions.

Why it matters

Who can join: the full rules

Inclusion 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 %.

Exclusion Criteria:

* 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 \<30mL/min/1.73m2) or liver dysfunction, with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) \> 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* Previously withdrawn from this study.

Where it's running

• InCor - HCFMUSP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Martino Martinelli Filho, PhD
• Email: martino@incor.usp.br
• Phone: +551126615515

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• RHYthm and Myocardial Function Relationship in Heart Disease

  This study tests how heart rhythm patterns relate to heart muscle function in adults with arrhythmias or cardiomyopathy.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07491237

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

  Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

• Tailored digital support to cut sedentary time in long-term cardiac rehab

  In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

  Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

• NT-proBNP–guided heart failure screening for people 65+ in rural China

  This study tests whether using NT-proBNP blood tests to guide heart failure screening in adults 65 and older in rural China can find unrecognized heart problems more effectively than symptom-based screening.

  Recruiting Jiangsu Taizhou People's Hospital · Nanjing · NCT07885488

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.