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Trial record 40 of 1126 for:    adenosine

Role and Interactions of Adenosine, Receptors, Methionine Cycle Nutritional, Metabolic and Genetic Determinants in the Onset of Atrial Fibrillation in Normal Heart (FACS)

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ClinicalTrials.gov Identifier: NCT02885740
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

The purpose of this study is to analyze the association of atrial fibrillation onset in normal heart and:

  • Genetic determinants (genes of receptors, enzymes involved in synthesis and degradation, genes of bioavailability of coenzymes and nutritional precursors)
  • Metabolic determinants of adenosine and methionine cycles
  • Nutritional determinants.

Secondary purposes are:

  • Analysis of physiopathologic mechanisms of AF in normal hearts and adenosine metabolisms and its interaction with methionine metabolism, according to identified genetic determinants
  • Analysis of blood markers of adenosine and methionine metabolites as phenotypic markers of detected polymorphisms
  • Evaluate the role of adenosine receptors in AF onset

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Quantification assay of adenosine and methionine cycle metabolites Genetic: Polymorphism analysis of genes related to adenosine metabolism and methionine cycle Other: Quantitative and qualitative nutritional evaluation Biological: Blood sample Not Applicable

Detailed Description:

Atrial fibrillation (AF) is the most frequent arrhythmia and its causes are not well known. Experimental and clinical studies showed that activation of parasympathetic system can induce and maintain AF. Adenosine is a cardiovascular modulator with effects on vascular tonus and activation of nodal tissue through the activation of A1, A2A, A2B et A3 receptors. Intracellular production of adenosine is directly dependent (30%) on the hydrolysis of S-adenosylhomocysteine (SAH) by S-adenosylhomocysteine hydrolase in methionine cycle. Cellular production of adenosine depends on ratio SAH/S-adenosylmethionine (SAM) and modulates the expression of receptors. Other potential interactions between this 2 metabolisms in AF are: 1) ratio SAM/SAH influences epigenetic mechanisms that can modify the expression of candidate genes involved in synaptic transmission and potassium canals, 2) ratio SAM/SAH influences also the cellular production of homocysteine with effects on cellular polarization, 3) adenosine and homocysteine are factors involved in thrombophilia and potentially associated to thromboembolic complications of AF.

This study will evaluate the genetic (micro SNP-array) and adenosine and methionine metabolic determinants in the physiopathology of AF in normal hearts.

Perspectives of this study are the prevention of AF in normal hearts through a nutritional and metabolic approach in subjects having a multigenic predisposition.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role and Interactions of Adenosine, Receptors, Methionine Cycle Nutritional, Metabolic and Genetic Determinants in the Onset of Atrial Fibrillation in Normal Heart
Study Start Date : March 2010
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atrial fibrillation in normal heart
Patients having atrial fibrillation in normal heart
Other: Quantification assay of adenosine and methionine cycle metabolites
Genetic: Polymorphism analysis of genes related to adenosine metabolism and methionine cycle
Other: Quantitative and qualitative nutritional evaluation
Questionnaire on consumption of 208 foods and drinks

Biological: Blood sample
Active Comparator: Control
Patients having a junctional supraventricular tachycardia in normal heart
Other: Quantification assay of adenosine and methionine cycle metabolites
Genetic: Polymorphism analysis of genes related to adenosine metabolism and methionine cycle
Other: Quantitative and qualitative nutritional evaluation
Questionnaire on consumption of 208 foods and drinks

Biological: Blood sample



Primary Outcome Measures :
  1. Frequency of genetic polymorphisms related to adenosine and methionine metabolism [ Time Frame: day 0 ]
    Increase of frequency in patients having an AF in normal heart

  2. Levels of adenosine and methionine cycle nutritional and metabolic determinants [ Time Frame: day 0 ]

Secondary Outcome Measures :
  1. Level of nutritional and methionine cycle metabolic determinants according to thromboembolic complications of AF in normal heart [ Time Frame: day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Affiliation to French social security plan

AF in normal heart:

- Atrial fibrillation in normal heart

Control:

- Junctional supraventricular tachycardia in normal heart

Normal heart: absence of macroscopic cardiomyopathy (echocardiography and normal ejection fraction)

Exclusion Criteria:

  • Considerable consumption of coffee (> 50 mg/day, 15 cups/day)
  • Actual administration of drugs interfering with adenosine metabolism: dipyridamole and methotrexate
  • Actual administration interfering with methionine metabolism: folates, methotrexate and anticonvulsants
  • Known renal insufficiency
  • Known hypo- or hyperthyroidism
  • Refusal or impossibility of informed consent
  • Pregnant or breastfeeding women
  • Person deprived of liberty
  • Person under legal protection or not able to consent
  • Person in emergency situation

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): NCT02885740


Contacts
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Contact: Etienne ALIOT, Pr e.aliot@chru-nancy.fr

Locations
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France
Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois Recruiting
Vandoeuvre Les Nancy, France
Contact: Etienne ALIOT, Pr         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Etienne ALIOT, Pr Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02885740     History of Changes
Other Study ID Numbers: 2009-A01197-50
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Adenosine
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action