NCT02885740

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

6.8 years

First QC Date

August 23, 2016

Last Update Submit

August 26, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Frequency of genetic polymorphisms related to adenosine and methionine metabolism

    Increase of frequency in patients having an AF in normal heart

    day 0

  • Levels of adenosine and methionine cycle nutritional and metabolic determinants

    day 0

Secondary Outcomes (1)

  • Level of nutritional and methionine cycle metabolic determinants according to thromboembolic complications of AF in normal heart

    day 0

Study Arms (2)

Atrial fibrillation in normal heart

EXPERIMENTAL

Patients having atrial fibrillation in normal heart

Other: Quantification assay of adenosine and methionine cycle metabolitesGenetic: Polymorphism analysis of genes related to adenosine metabolism and methionine cycleOther: Quantitative and qualitative nutritional evaluationBiological: Blood sample

Control

ACTIVE COMPARATOR

Patients having a junctional supraventricular tachycardia in normal heart

Other: Quantification assay of adenosine and methionine cycle metabolitesGenetic: Polymorphism analysis of genes related to adenosine metabolism and methionine cycleOther: Quantitative and qualitative nutritional evaluationBiological: Blood sample

Interventions

Quantification assay of adenosine and methionine cycle metabolitesOTHER
Atrial fibrillation in normal heartControl
Polymorphism analysis of genes related to adenosine metabolism and methionine cycleGENETIC
Atrial fibrillation in normal heartControl
Quantitative and qualitative nutritional evaluationOTHER

Questionnaire on consumption of 208 foods and drinks

Atrial fibrillation in normal heartControl
Blood sampleBIOLOGICAL
Atrial fibrillation in normal heartControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois

Vandœuvre-lès-Nancy, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Etienne ALIOT, Pr

    Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne ALIOT, Pr

CONTACT

e.aliot@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 31, 2016

Study Start

March 1, 2010

Primary Completion

January 1, 2017

Study Completion

October 1, 2017

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)