Atrial FibrillationNCT03592732
The Role of Adipokines In Atrial Fibrillation
An observational study of Atrial Fibrillation and Adiposity, run by University of Athens at 1 site in Greece.
Trial summary
The principal aim of the present study is to analyze adiponectin, omentin-1, apelin and visfatin plasma levels in patients with and without AF in an effort to identify their potential role in the development of AF. Read more about this study
- Who is it for?
- Ages Up to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Adiposity, Adiponectin
- What is being tested?
- Blood sample
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 29 Mar 2018to 29 Jan 2021
- 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 Up to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All participants will undergo either electrocardiogram or 24-hour Holter monitoring. AF patients will be divided into the following three groups: paroxysmal AF, persistent AF and permanent AF.Blood samples will be collected after 12-hour overnight fasting. Plasma adiponectin, omentin-1, apelin and visfatin levels will be measured by the Elisa method. Natriuretic peptide, C-reactive protein (CRP) and parameters concerning lipid profile (total cholesterol, triglycerides, low-density cholesterol, high-density cholesterol), glycemic profile (plasma glucose, hemoglobin A1c) and renal function (urea, creatinine) will be measured by standardized enzymatic methods as well. Transthoracic echocardiography will be performed in every patient.
Who may be able to join
- healthy subjects without atrial fibrillation and subjects with paroxysmal, persistent or permanent atrial fibrillation
Who cannot join
- Patients with coronary artery disease, acute coronary syndrome, heart failure (EF<50%), cardiomyopathy, cancer, significant valvular disease, rheumatic heart disease, chronic kidney disease (eGRF<30) or stroke will be excluded.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
LAIKO General Hospital, Athens, Greece
Athens, 11522
Maria Velliou, MD, maravelliou84@yahoo.gr
About this study
Official title: The Impact Of Adipokines Levels In Patients With Atrial Fibrillation
The principal aim of the present study is to analyze adiponectin, omentin-1, apelin and visfatin plasma levels in patients with and without AF in an effort to identify their potential role in the development of AF.
Read the detailed description
Introduction Adipose tissue is no longer considered a triglycerides-storage depot, but it has been recognized as an endocrine organ that regulates sugar and fat metabolism and energy homeostasis and implicates in cardiovascular (CV) function through the release of bioactive factors, the so-called adipokines. Several adipokines including adiponectin, omentin-1, apelin and visfatin have been identified as well as their link with CV diseases and, particularly, coronary artery disease (CAD) (1-3).
However, the potential impact of adipokines in patients with atrial fibrillation (AF) has not still elucidated. Although, there is evidence that apelin (4,5) and omentin-1 (6) are inversely correlated with AF, available data in regard to adiponectin and visfatin are inconclusive (7-9).
Objectives The principal aim of the present study is to calculate adiponectin, omentin-1, apelin and visfatin plasma levels in patients with AF and controls matched for age and gender in an effort to identify their potential role in the development of AF.
Methods Study population. Overall, 40 patients with AF and 40 controls will be studied. Patients with CAD, heart failure, cardiomyopathy, cancer, significant valvular disease, rheumatic heart disease or stroke will be excluded. The present study is conducted in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of our Hospital. A written informed consent will be obtained from each participant.
A detailed profile including demographic characteristics (age, gender) and traditional CV risk factors (smoking, hypertension, dyslipidemia, diabetes mellitus) will be obtained from every patient. Body mass index was (BMI) will be calculated as bodyweight in kilograms divided by height in meters squared and will be estimated for all subjects. All participants will undergo either electrocardiogram or 24-hour Holter monitoring. AF patients will be divided into the following three groups: paroxysmal AF, persistent AF and permanent AF.
Definitions. Paroxysmal AF is defined as a history of one or more episodes of AF that were treated with pharmacological or electrical cardioversion within seven days. Persistent AF is defined a history of one or more episodes of AF over seven days that required pharmacological or electrical cardioversion) and permanent AF is defined as continuous AF for more than a year.
Echocardiography. Transthoracic echocardiography will be performed in every patient. Left atrial dimension, interventricular septal dimension, left ventricular (LV) end diastolic dimension and ejection fraction (EF) will be measured.
Laboratory analysis. Blood samples will be collected after 12-hour overnight fasting. Plasma adiponectin (RD195023100,Human Adiponectin, Elisa Bio Vendor Laboratory, Medicine Inc., Brno, Czech Republic), omentin-1, apelin (Phoenix Pharmaceuticals Inc, Burlingame, CA) and visfatin (Phoenix Pharmaceuticals, California, CA, USA) levels will be measured by the Elisa method. Natriuretic peptide, C-reactive protein (CRP) and parameters concerning lipid profile (total cholesterol, triglycerides, low-density cholesterol, high-density cholesterol), glycemic profile (plasma glucose, hemoglobin A1c) and renal function (urea, creatinine) will be measured by standardized enzymatic methods as well.
Statistical analysis. Continuous variables will be expressed as mean values ± standard deviation (SD). Comparisons of continuous variables will be performed by one-way analysis of variance (ANOVA). Categorical data will be expressed as absolute and relative frequencies. All data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 18.0 and all tests will be 2-tailed with the 5% indicating level of significance.
- Being tested
- Blood sample
- Medical subject headings
- Atrial Fibrillation, Obesity, Obesity, Abdominal, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| A | Patients with atrial fibrillation Receives: Other: Blood sample | |
| B | Patients without atrial fibrillation Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
adiponectin, omentin-1, apelin and visfatin plasma levels
adiponectin, omentin-1, apelin and visfatin plasma levels calculation by the Eliza method
Measured: blood sample collection analysis (day zero
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start29 Mar 2018
- Primary completion29 Jan 2021
- Study completion29 Jan 2021 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Velliou, University of Athens
- Investigators
- Elias Sanidas, MD, PhD, Principal investigator, Dept. of Cardiology, ESH Excellence Center, LAIKO General Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592732
- Sponsor's protocol ID
- 308/29-3-2018
- Status last verified
- Jan 2021
- First submitted
- 28 Jun 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Adipokines Levels In Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03592732
- Acronym / sponsor ID
- 308/29-3-2018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (estimated)
- First posted
- 19 Jul 2018 (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.
The principal aim of the present study is to analyze adiponectin, omentin-1, apelin and visfatin plasma levels in patients with and without AF in an effort to identify their potential role in the development of AF.
Detailed description
Introduction Adipose tissue is no longer considered a triglycerides-storage depot, but it has been recognized as an endocrine organ that regulates sugar and fat metabolism and energy homeostasis and implicates in cardiovascular (CV) function through the release of bioactive factors, the so-called adipokines. Several adipokines including adiponectin, omentin-1, apelin and visfatin have been identified as well as their link with CV diseases and, particularly, coronary artery disease (CAD) (1-3).
However, the potential impact of adipokines in patients with atrial fibrillation (AF) has not still elucidated. Although, there is evidence that apelin (4,5) and omentin-1 (6) are inversely correlated with AF, available data in regard to adiponectin and visfatin are inconclusive (7-9).
Objectives The principal aim of the present study is to calculate adiponectin, omentin-1, apelin and visfatin plasma levels in patients with AF and controls matched for age and gender in an effort to identify their potential role in the development of AF.
Methods Study population. Overall, 40 patients with AF and 40 controls will be studied. Patients with CAD, heart failure, cardiomyopathy, cancer, significant valvular disease, rheumatic heart disease or stroke will be excluded. The present study is conducted in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of our Hospital. A written informed consent will be obtained from each participant.
A detailed profile including demographic characteristics (age, gender) and traditional CV risk factors (smoking, hypertension, dyslipidemia, diabetes mellitus) will be obtained from every patient. Body mass index was (BMI) will be calculated as bodyweight in kilograms divided by height in meters squared and will be estimated for all subjects. All participants will undergo either electrocardiogram or 24-hour Holter monitoring. AF patients will be divided into the following three groups: paroxysmal AF, persistent AF and permanent AF.
Definitions. Paroxysmal AF is defined as a history of one or more episodes of AF that were treated with pharmacological or electrical cardioversion within seven days. Persistent AF is defined a history of one or more episodes of AF over seven days that required pharmacological or electrical cardioversion) and permanent AF is defined as continuous AF for more than a year.
Echocardiography. Transthoracic echocardiography will be performed in every patient. Left atrial dimension, interventricular septal dimension, left ventricular (LV) end diastolic dimension and ejection fraction (EF) will be measured.
Laboratory analysis. Blood samples will be collected after 12-hour overnight fasting. Plasma adiponectin (RD195023100,Human Adiponectin, Elisa Bio Vendor Laboratory, Medicine Inc., Brno, Czech Republic), omentin-1, apelin (Phoenix Pharmaceuticals Inc, Burlingame, CA) and visfatin (Phoenix Pharmaceuticals, California, CA, USA) levels will be measured by the Elisa method. Natriuretic peptide, C-reactive protein (CRP) and parameters concerning lipid profile (total cholesterol, triglycerides, low-density cholesterol, high-density cholesterol), glycemic profile (plasma glucose, hemoglobin A1c) and renal function (urea, creatinine) will be measured by standardized enzymatic methods as well.
Statistical analysis. Continuous variables will be expressed as mean values ± standard deviation (SD). Comparisons of continuous variables will be performed by one-way analysis of variance (ANOVA). Categorical data will be expressed as absolute and relative frequencies. All data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 18.0 and all tests will be 2-tailed with the 5% indicating level of significance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Blood samplePatients with atrial fibrillation |
| B | – | Other: Blood samplePatients without atrial fibrillation |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants will undergo either electrocardiogram or 24-hour Holter monitoring. AF patients will be divided into the following three groups: paroxysmal AF, persistent AF and permanent AF.Blood samples will be collected after 12-hour overnight fasting. Plasma adiponectin, omentin-1, apelin and visfatin levels will be measured by the Elisa method. Natriuretic peptide, C-reactive protein (CRP) and parameters concerning lipid profile (total cholesterol, triglycerides, low-density cholesterol, high-density cholesterol), glycemic profile (plasma glucose, hemoglobin A1c) and renal function (urea, creatinine) will be measured by standardized enzymatic methods as well. Transthoracic echocardiography will be performed in every patient.
Key inclusion criteria (1 listed)
- healthy subjects without atrial fibrillation and subjects with paroxysmal, persistent or permanent atrial fibrillation
Key exclusion criteria (1 listed)
- Patients with coronary artery disease, acute coronary syndrome, heart failure (EF<50%), cardiomyopathy, cancer, significant valvular disease, rheumatic heart disease, chronic kidney disease (eGRF<30) or stroke will be excluded.
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 |
|---|---|---|
| Blood sampleBlood sample | Other | A, B |
Primary outcome
adiponectin, omentin-1, apelin and visfatin plasma levels
Time frame: blood sample collection analysis (day zero
adiponectin, omentin-1, apelin and visfatin plasma levels calculation by the Eliza method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Elias Sanidas, MD, PhD principal investigator
Dept. of Cardiology, ESH Excellence Center, LAIKO General Hospital, Athens, Greece
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 and Adiposity, run by University of Athens at 1 site in Greece.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Feb 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Velliou, MD (+306977445920, maravelliou84@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adiponectin, omentin-1, apelin and visfatin plasma levels (time frame: blood sample collection analysis (day zero). 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 1 Feb 2021.