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

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ClinicalTrials.gov Identifier: NCT04128878
Recruitment Status : Completed
First Posted : October 16, 2019
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Samir Saba, University of Pittsburgh

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Sotalol Drug: Dofetilide

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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Change in microvascular endothelium dependent dilation following anti-arrhythmic therapy as measured in perfusion units [ Time Frame: 1 year ]
    Change in microvascular endothelium dependent dilation (in response to acetylcholine) assessed with laser speckle contrast imaging after initiating antiarrhythmic medical therapy.


Secondary Outcome Measures :
  1. Correlation between microvascular endothelial dysfunction measured at baseline and atrial fibrillation recurrence. [ Time Frame: 1 year ]
  2. Correlation between microvascular endothelial function improvement with antiarrhythmic medications and atrial fibrillation recurrence. [ Time Frame: 1 year ]
  3. Correlation between microvascular endothelial function and atrial fibrillation severity represented by left atrial size and type of Afib (paroxysmal vs persistent). [ Time Frame: 1 year ]
  4. Change in other vasodilation dysfunction indices measured after initiating antiarrhythmic medical therapy. [ Time Frame: 1 year ]
  5. Correlation between vasodilation dysfunction indices measured at baseline and atrial fibrillation recurrence. [ Time Frame: 1 year ]
  6. Whether missense mutation in Cyb5R3 T117S can predict atrial fibrillation recurrence. [ Time Frame: 1 year ]
  7. Whether missense mutation in Cyb5R3 T117S is correlated with atrial fibrillation severity. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Exclusion criteria will include:

  • 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
  • active malignancy
  • poorly controlled connective tissue disease
  • any acute or chronic inflammatory or infectious disease
  • Patients who are already on class I or class III antiarrhythmic agents will be excluded from the study
  • Patients on non-dihydropyridine calcium channel blockers and beta blockers will not be excluded from the study, as these agents are not considered anti-arrhythmics and are not hypothesized to affect endothelial function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128878


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center - Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States, 15201
Sponsors and Collaborators
Samir Saba
Investigators
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Principal Investigator: Samir Saba, MD Chief, Division of Cardiology, University of Pittsburgh Medical Center
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Responsible Party: Samir Saba, Chief, Division of Cardiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04128878    
Other Study ID Numbers: STUDY18090003
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sotalol
Dofetilide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Potassium Channel Blockers
Membrane Transport Modulators