NCT04128878

Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Samir Saba · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

This is a prospective, observational study that will examine endothelial dysfunction in atrial fibrillation before and after treatment with anti-arrhythmic agents and the extent to which baseline endothelial dysfunction improves after treatment.

Detailed description

This will be a prospective, observational study and roughly 60 patients will be recruited based on strict inclusion/exclusion criteria. Goal population includes adult patients with a diagnosis of paroxysmal or persistent atrial fibrillation seen in the electrophysiology clinic and admitted to the UPMC Presbyterian electrophysiology service for initiation of anti-arrhythmic medications. The primary goal of the study will be to evaluate the degree of endothelial function recovery seen after initiating anti-arrhythmic medical therapy. We will assess genetic markers, arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature. Testing will be performed at baseline prior to the 1st dose of anti- arrhythmic therapy and repeated again 1-3 months later at outpatient follow-up visit. Additionally, follow-up phone calls or office visits will take place at 6 and 12 months after the initial data collection visit to document recurrence rate of atrial fibrillation.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Sotalol	The primary goal of the study will be to evaluate the change in endothelial function seen after initiating anti-arrhythmic medical therapy. Testing will be performed at baseline prior to the 1st dose of anti-arrhythmic therapy and again 1-3 months later at outpatient follow-up visit. We will record the resting flow (RF), biological zero (BZ) and peak flow (PF) as perfusion units (PU). Specifically, we will assess arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature.
DRUG	Dofetilide	Same as described above with sotalol.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-10-16
• Last updated: 2021-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study