Treatment Strategy of Vasovagal Syncope

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Mar 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well a treatment called CNA can help prevent repeated fainting episodes (known as vasovagal syncope) compared to a medication called midodrine. The study involves multiple locations and is currently recruiting participants. If you are an adult aged 18 or older who has fainted more than three times in the past year and have tried other treatments without success, you may be eligible to join. Participants will need to have a positive response to a specific test that checks how your body reacts to being upright.

If you choose to participate, you will receive the assigned treatment and will be monitored closely throughout the study. It’s important to note that individuals with certain heart conditions or those who have recently undergone specific heart procedures will not be eligible for this trial. If you are interested in taking part, you will need to provide your consent and be willing to attend follow-up appointments. This trial aims to find better ways to manage fainting episodes, so your involvement could help improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years of age
• • 2. Calgary Syncope Symptom Score ≥ -2 points
• • 3. Positive response to head-up tilt test
• • 4. With syncope episodes more than 3 times in the preceding year
• • 5. A proven failure of non-pharmacologic treatment, including reassurance regarding the benign prognosis, education about the avoidance of situations and triggers initiating syncope， application of PCM during the occurrence of prodromal symptoms, and lifestyle modifications（adequate fluid intake and salt supplementation）， according to the guideline
• • 6. Willingness to comply with follow-up requirements and to sign the informed consent
• Exclusion Criteria:
• • 1. Complied with other causes of syncope, including postural hypotension, aortic stenosis, sick sinus node syndrome, high-grade atrioventricular block, ventricular arrhythmias, pulmonary hypertension, hypertrophic cardiomyopathy, transient ischemic attack, epilepsy, sequelae of cerebral infarction or cerebral hemorrhage, subclavian vein steal syndrome and drug-induced syncope.
• • 2. Complied with congenital heart disease, valvular heart disease, cardiomyopathy, and diabetes.
• • 3. History of cardiac catheter ablation, peacemaker implantation and cardiac surgery.
• • 4. History of midodrine usage, or compiled with contradiction of midodrine, including urine retention, hypertension (Bp≥140/90mmHg), glaucoma， renal dysfunction.
• • 5. Life expectancy \<1 year for any medical condition
• • 6. Pregnancy or breast-feeding