A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital
A Prospective Randomized Study of Different Digoxin Treatment Regimens in Egyptian Hospital
1 other identifier
interventional
71
0 countries
N/A
Brief Summary
Digoxin is the primary cardiac glycoside in clinical use. Because of the narrow therapeutic index and risk of toxicity, therapeutic drug monitoring is highly recommended. In Egypt, most cardiologists give digoxin holiday for both atrial fibrillation and heart failure, it is not clear if the interrupted digoxin regimens are effective since serum digoxin concentrations might fall below the therapeutic range. Objective: To evaluate and compare the digoxin serum concentration and patient's quality of life in the continuous versus interrupted digoxin dosing regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 atrial-fibrillation
Started Oct 2012
Shorter than P25 for phase_4 atrial-fibrillation
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
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedJuly 7, 2015
July 1, 2015
2 years
July 1, 2015
July 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
measuring digoxin trough steady state plasma concentrations for the interrupted and continuous treatment regimens
1 month
Secondary Outcomes (2)
evaluating patients quality of life using quality of life questionnaire for atrial fibrillation patients
1 month
evaluating signs and symptoms of digoxin side effects and toxicity by using specific structured questions
1 month
Study Arms (4)
Regimen 1
ACTIVE COMPARATORpatient takes 0.25mg of digoxin daily except friday
Regimen 2
ACTIVE COMPARATORpatient takes 0.25mg of digoxin daily except Thursday and Friday
Regimen 3
ACTIVE COMPARATORpatient takes 0.125mg of digoxin daily
Regimen 4
ACTIVE COMPARATORdigoxin dose is calculated using Jusko-Koup method and given daily
Interventions
Eligibility Criteria
You may qualify if:
- Patients with atrial fibrillation (AF)
- with or without congestive heart failure (CHF)
- taking digoxin tablets with or without holiday regimens
You may not qualify if:
- taking the following drugs concurrently: amiodarone, verapamil, quinidine and propafenone.
- diagnosed with thyroid disorders (hyperthyroidism \& hypothyroidism).
- diagnosed with renal failure
- pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Assistant
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 3, 2015
Study Start
October 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
July 7, 2015
Record last verified: 2015-07