Atrial FibrillationNCT04128878
Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients
An observational study of Atrial Fibrillation, run by Samir Saba at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Sotalol and Dofetilide
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- age >75 years
- history of cardiomyopathy
- history of severe cardiac valvular disease
- history of coronary artery disease
- pulmonary artery hypertension
- congenital heart disease
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center - Presbyterian University Hospital
Pittsburgh, Pennsylvania, 15201
About this study
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.
Read the 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
- Being tested
- Sotalol, Dofetilide
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotalolDrug
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.
DofetilideDrug
Same as described above with sotalol.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Sotalol; Drug: Dofetilide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (7)
Correlation between microvascular endothelial dysfunction measured at baseline and atrial fibrillation recurrence.
Measured: 1 year
Correlation between microvascular endothelial function improvement with antiarrhythmic medications and atrial fibrillation recurrence.
Measured: 1 year
Correlation between microvascular endothelial function and atrial fibrillation severity represented by left atrial size and type of Afib (paroxysmal vs persistent).
Measured: 1 year
Change in other vasodilation dysfunction indices measured after initiating antiarrhythmic medical therapy.
Measured: 1 year
Correlation between vasodilation dysfunction indices measured at baseline and atrial fibrillation recurrence.
Measured: 1 year
Whether missense mutation in Cyb5R3 T117S can predict atrial fibrillation recurrence.
Measured: 1 year
Whether missense mutation in Cyb5R3 T117S is correlated with atrial fibrillation severity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 May 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samir Saba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samir Saba, University of Pittsburgh
- Investigators
- Samir Saba, MD, Principal investigator, Chief, Division of Cardiology, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128878
- Sponsor's protocol ID
- STUDY18090003
- Status last verified
- Jan 2021
- First submitted
- 14 Oct 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT04128878
- Acronym / sponsor ID
- STUDY18090003
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Samir SabaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation Cohort | – | Drug: Sotalol, Drug: DofetilideAdult 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- age >75 years
- history of cardiomyopathy
- history of severe cardiac valvular disease
- history of coronary artery disease
- pulmonary artery hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotalolThe 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 | Atrial Fibrillation Cohort |
| DofetilideSame as described above with sotalol. | Drug | Atrial Fibrillation Cohort |
Primary outcome
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.
7 secondary outcomes
Correlation between microvascular endothelial dysfunction measured at baseline and atrial fibrillation recurrence.
Time frame: 1 year
Correlation between microvascular endothelial function improvement with antiarrhythmic medications and atrial fibrillation recurrence.
Time frame: 1 year
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
Change in other vasodilation dysfunction indices measured after initiating antiarrhythmic medical therapy.
Time frame: 1 year
Correlation between vasodilation dysfunction indices measured at baseline and atrial fibrillation recurrence.
Time frame: 1 year
Whether missense mutation in Cyb5R3 T117S can predict atrial fibrillation recurrence.
Time frame: 1 year
Whether missense mutation in Cyb5R3 T117S is correlated with atrial fibrillation severity.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Saba, MD principal investigator
Chief, Division of Cardiology, University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Samir Saba at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microvascular endothelium dependent dilation following anti-arrhythmic therapy as measured in perfusion units (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.