Using video-assisted surgery to control heart rhythm issues in Chagas disease patients
Role of Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease - Pilot Study Randomized Controlled Trial
This study is testing a new surgery to see if it can help Chagas disease patients with heart rhythm problems feel better and have fewer episodes of fast heartbeats.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (Sao Paulo) |
| Trial ID | NCT04239144 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bilateral sympathectomy, a surgical procedure, in reducing episodes of ventricular tachycardia (VT) in patients suffering from Chagas cardiomyopathy. It compares this intervention against catheter ablation and optimal medical therapy in a randomized, open-label format. The trial includes 45 patients divided into three groups, with outcomes assessed over six months to one year, focusing on VT recurrence, hospital stay length, and left ventricular function. The study aims to provide a new treatment option for patients with recurrent VT who have not responded adequately to existing therapies.
Who should consider this trial
Good fit: Ideal candidates are adults with Chagas disease cardiomyopathy who have an implantable cardio-defibrillator and have experienced multiple appropriate ICD therapies.
Not a fit: Patients with severe comorbidities, such as unstable angina or severe heart valve issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of life-threatening arrhythmias and improve the quality of life for patients with Chagas disease.
How similar studies have performed: While the use of bilateral sympathectomy for VT is less common, similar approaches have shown promise in treating refractory arrhythmias in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Chagas Disease Cardiomyopathy having an ICD * At least four appropriate ICD therapies in the past six months, documented by device interrogation or medical records; * Use of amiodarone and beta blockers in an optimized fashion; * Life expectancy of more than one year * Conditions for following the plan of clinical follow-up of the study. Exclusion criteria: * Presence of an absolute contraindication to receive any of the possible treatments of the study; * Pregnant Woman; * Less than 18 years-old; * Renal insufficiency with creatinine \>2.5 mg/dL (221 umol/L); * Mobile thrombus in the left ventricle; * Left Ventricle Ejection fraction \< 10%; * Unstable angina; * Severe aortic stenosis * Primary severe mitral insufficiency; * New York Heart Association (NYHA) functional class IV; * Previous cardiac surgery or scheduled.
Where this trial is running
Sao Paulo
- Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — Sao Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Paulo M Pego Fernandes, MD, PhD — Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)
- Study coordinator: Paulo M Pego Fernandes, PhD
- Email: paulo.fernandes@incor.usp.br
- Phone: +551126615921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.