Atrial FibrillationFACSNCT02885740
Role and Interactions of Adenosine, Receptors, Methionine Cycle Nutritional, Metabolic and Genetic Determinants in the Onset of Atrial Fibrillation in Normal Heart
A study testing Quantification assay of adenosine and methionine cycle metabolites, Polymorphism analysis of genes related to adenosine metabolism and methionine cycle and Quantitative and qualitative nutritional evaluation in people with Atrial Fibrillation, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Quantification assay of adenosine and methionine cycle metabolites, Polymorphism analysis of genes related to adenosine metabolism and methionine cycle and Quantitative and qualitative nutritional evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Oct 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- Pregnant or breastfeeding women
- Person deprived of liberty
- Person under legal protection or not able to consent
- Person in emergency situation
Trial locations and contacts
1 site in 1 country.
Etienne ALIOT, Pr contact
France1 site, 1 recruiting
- Recruiting
Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois
Vandœuvre-lès-Nancy
Etienne ALIOT, Pr
About this study
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.
Read more
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
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Quantification assay of adenosine and methionine cycle metabolites, Polymorphism analysis of genes related to adenosine metabolism and methionine cycle, Quantitative and qualitative nutritional evaluation, Blood sample
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantification assay of adenosine and methionine cycle metabolitesOther
Polymorphism analysis of genes related to adenosine metabolism and methionine cycleGenetic
Quantitative and qualitative nutritional evaluationOther
Questionnaire on consumption of 208 foods and drinks
Blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation in normal heart | Experimental | Patients having atrial fibrillation in normal heart Receives: 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 |
| Control | Active comparator | Patients having a junctional supraventricular tachycardia in normal heart Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of genetic polymorphisms related to adenosine and methionine metabolism
Increase of frequency in patients having an AF in normal heart
Measured: day 0
Levels of adenosine and methionine cycle nutritional and metabolic determinants
Measured: day 0
Secondary outcomes (1)
Level of nutritional and methionine cycle metabolic determinants according to thromboembolic complications of AF in normal heart
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startMar 2010
- Primary completionJan 2017 (estimated)
- Study completionOct 2017 (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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne ALIOT, Pr, Principal investigator, Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885740
- Sponsor's protocol ID
- 2009-A01197-50
- Acronym
- FACS
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Interactions of Adenosine, Receptors, Methionine Cycle Nutritional, Metabolic and Genetic Determinants in the Onset of Atrial Fibrillation in Normal Heart
- ClinicalTrials.gov ID
- NCT02885740
- Acronym / sponsor ID
- FACS / 2009-A01197-50
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- 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 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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation in normal heart | Experimental | 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 samplePatients having atrial fibrillation in normal heart |
| Control | Active comparator | 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 samplePatients having a junctional supraventricular tachycardia in normal heart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent
- Affiliation to French social security plan
- Atrial fibrillation in normal heart
- Junctional supraventricular tachycardia in normal heart
- Normal heart: absence of macroscopic cardiomyopathy (echocardiography and normal ejection fraction)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Quantification assay of adenosine and methionine cycle metabolites | Other | Atrial fibrillation in normal heart, Control |
| Polymorphism analysis of genes related to adenosine metabolism and methionine cycle | Genetic | Atrial fibrillation in normal heart, Control |
| Quantitative and qualitative nutritional evaluationQuestionnaire on consumption of 208 foods and drinks | Other | Atrial fibrillation in normal heart, Control |
| Blood sample | Biological | Atrial fibrillation in normal heart, Control |
Primary outcome
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
Levels of adenosine and methionine cycle nutritional and metabolic determinants
Time frame: day 0
1 secondary outcome
Level of nutritional and methionine cycle metabolic determinants according to thromboembolic complications of AF in normal heart
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Etienne ALIOT, Pr contact
Etienne ALIOT, Pr principal investigator
Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantification assay of adenosine and methionine cycle metabolites, Polymorphism analysis of genes related to adenosine metabolism and methionine cycle and Quantitative and qualitative nutritional evaluation in people with Atrial Fibrillation, run by Central Hospital, Nancy, France at 1 site in France.
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 7 inclusion and 10 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 31 Aug 2016. 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 France. 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 Etienne ALIOT, Pr (e.aliot@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of genetic polymorphisms related to adenosine and methionine metabolism (time frame: day 0). The study lists 2 primary outcomes in all. 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 31 Aug 2016.