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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Maria Velliou, MD contact

+306977445920

maravelliou84@yahoo.gr

Greece1 site, 1 recruiting
  • LAIKO General Hospital, Athens, Greece

    Athens, 11522

    Maria Velliou, MD, maravelliou84@yahoo.gr

    Recruiting

Other trials in Greece

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 groups in NCT03592732
Study groupRoleWhat they receive
APatients with atrial fibrillation
Receives: Other: Blood sample
BPatients without atrial fibrillation
Receives: Other: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted19 Jul 2018
  2. Study start29 Mar 2018
  3. Primary completion29 Jan 2021
  4. Study completion29 Jan 2021 (estimated)

Resources

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)
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

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.

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