Role of SNP and DIGOXIN Response in Atrial Fibrillation Patients
Role of Genetic Factors in the Response to Digoxin in the Acute Treatment of Atrial Fibrillation
1 other identifier
observational
150
1 country
1
Brief Summary
This study tested the hypothesis that response to digoxin is modulated by single Nucleotid Polymorphism (SNP):
- Multi Drug Resistance (MDR1) gene haplotypes and Solute carrier organic anion transporter family member 1B3 (SLCO1B3) gene Polymorphism and their role in the response to treatement.
- Aldosterone synthase (CYP11B2) gene and sodium channel, voltage-gated, type V alpha subunit gene (SCN5A) correlated with atrial fibrillation and their roles in response to digoxin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 16, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 12, 2020
February 1, 2020
3.4 years
June 16, 2014
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between the response to digoxin and the genotypes of the patients
In the current study we aimed at outlining the different MDR-1, SLCO1B3, CYP11B12 and SCN5A genotypes in a sample of Tunisian patients, suffering from AF and taking digoxin, to assess the role of SNPs in affecting serum digoxin concentrations, and studying the consequences on patients' clinical outcome. Patients will be monitored for 24 hours in an intensive care unit;
24 hours
Secondary Outcomes (1)
Rhythm and Rate control
24 hours
Other Outcomes (1)
Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)
24 hours
Study Arms (1)
Digoxin and AF
Patients consulting the emergency deprtment (ED) for AF and receiving Digoxin treatment
Interventions
Patients consulting the ED for Acute onset AF received 0.5 mg digoxin by oral root
Eligibility Criteria
All patients presenting at the ED with acute onset AF documented by ECG.
You may qualify if:
- Patients older than 20 years
- Quick AF (heart rate\> 120 bpm) diagnosed by ECG
You may not qualify if:
- HR under 120 bpm
- Hemodynamically unstable patients
- Atrio-Ventricular-block (second or third degree)
- Ventricular rhythm disorder
- Acute coronary syndrome
- kidney failure
- Hypokalimia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university of Monastir
Monastir, 5000, Tunisia
Related Links
Biospecimen
arterial blood samples collected in EDTA tubes and stored in - 20°C envirement for DNA extraction with salting out methods.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nouira Samir, Professor
University of Monastir
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2014
First Posted
June 18, 2014
Study Start
July 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 12, 2020
Record last verified: 2020-02