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

NCT04128878 | Completed FDA Drug

• 1 other identifier: STUDY18090003
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Change in microvascular endothelium dependent dilation following anti-arrhythmic therapy as measured in perfusion units

  Change in microvascular endothelium dependent dilation (in response to acetylcholine) assessed with laser speckle contrast imaging after initiating antiarrhythmic medical therapy.

  1 year

Secondary Outcomes (7)

• Correlation between microvascular endothelial dysfunction measured at baseline and atrial fibrillation recurrence.

  1 year

• Correlation between microvascular endothelial function improvement with antiarrhythmic medications and atrial fibrillation recurrence.

  1 year

• Correlation between microvascular endothelial function and atrial fibrillation severity represented by left atrial size and type of Afib (paroxysmal vs persistent).

  1 year

• Change in other vasodilation dysfunction indices measured after initiating antiarrhythmic medical therapy.

  1 year

• Correlation between vasodilation dysfunction indices measured at baseline and atrial fibrillation recurrence.

  1 year

Study Arms (1)

Atrial Fibrillation Cohort

Adult patients with known or new diagnosis of either paroxysmal or persistent atrial fibrillation seen at the electrophysiology outpatient clinic and admitted to the electrophysiology service for initiation of anti-arrhythmic medications (dofetilide or sotalol).

Drug: Sotalol; Drug: Dofetilide

Interventions

Sotalol DRUG

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.

Atrial Fibrillation Cohort

Dofetilide DRUG

Same as described above with sotalol.

Atrial Fibrillation Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with known or new diagnosis of either paroxysmal or persistent atrial fibrillation seen at the electrophysiology outpatient clinic and admitted to the electrophysiology service for initiation of anti-arrhythmic medications.

You may qualify if:

• Adult patients (18-75 years of age) with paroxysmal or persistent atrial fibrillation
• Patients who recovered from prior tachycardia induced cardiomyopathy will be allowed to enroll in the study.

You may not qualify if:

• age \>75 years
• history of cardiomyopathy
• history of severe cardiac valvular disease
• history of coronary artery disease
• pulmonary artery hypertension
• congenital heart disease
• history of stroke
• chronic hypoxia
• recent worsening or flare up of obstructive or restrictive lung disease
• liver cirrhosis
• stage three or worse chronic kidney disease
• any major trauma or surgery within the preceding 3 months
• uncontrolled hyperthyroidism
• uncontrolled hypertension
• uncontrolled diabetes mellitus

Sponsors & Collaborators

• Samir Saba: lead

Study Sites (1)

University of Pittsburgh Medical Center - Presbyterian University Hospital

Pittsburgh, Pennsylvania, 15201, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Sotalol; dofetilide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Samir Saba, MD

  Chief, Division of Cardiology, University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Division of Cardiology

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)