Cardiac Autonomic Denervation for Cardio-inhibitory Syncope

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Oct 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach called cardiac autonomic denervation for patients who experience a specific type of fainting called cardio-inhibitory syncope. This condition is often linked to a problem with how the heart responds to signals from the nervous system, leading to episodes of slow heart rate (bradycardia) and fainting. The researchers believe that modifying the autonomic nervous system could help improve symptoms better than a placebo (a treatment that has no active ingredients).

To participate in this trial, individuals must be between 18 and 70 years old and have had a documented cardio-inhibitory response during specific tests or monitoring that shows a connection between their fainting episodes and heart rate changes. Those with certain heart conditions or other medical issues, such as thyroid problems or sleep apnea, will not be eligible. Although the trial is not yet recruiting participants, those who take part can expect to receive either the new treatment or a placebo, and they will be monitored closely throughout the study. This trial aims to provide more solid evidence on the effectiveness of this treatment approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged between 18 and 70 years old.
• • Cardio-inhibitory response (VASIS 2A or 2B) during tilt test, or after carotid sinus massage.
• • Patients with bradycardia mediated by vagal hypertonia documented on 24-hour Holter monitoring and a clear relationship with symptoms.
• Exclusion Criteria:
• • Ages under 18 and over 70
• • Presence of structural heart disease documented by echocardiography.
• • Hypothyroidism and hyperthyroidism, drug effects, obstructive sleep apnea and other causes of secondary bradycardia.
• • Anatomical disease of the conduction system.