A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
patients take 0.25 mg of digoxin daily except friday
patients take 0.25 mg of digoxin daily except thursday and friday
patients take 0.125 mg of digoxin daily
digoxin dose is calculated using Jusko-Koup method and given daily
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients with atrial fibrillation (AF)
- with or without congestive heart failure (CHF)
- taking digoxin tablets with or without holiday regimens
Exclusion Criteria:
- taking the following drugs concurrently: amiodarone, verapamil, quinidine and propafenone.
- diagnosed with thyroid disorders (hyperthyroidism & hypothyroidism).
- diagnosed with renal failure
- pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Regimen 1
Regimen 2
Regimen 3
Regimen 4
Arm Description
patient takes 0.25mg of digoxin daily except friday
patient takes 0.25mg of digoxin daily except Thursday and Friday
patient takes 0.125mg of digoxin daily
digoxin dose is calculated using Jusko-Koup method and given daily
Outcomes
Primary Outcome Measures
measuring digoxin trough steady state plasma concentrations for the interrupted and continuous treatment regimens
Secondary Outcome Measures
evaluating patients quality of life using quality of life questionnaire for atrial fibrillation patients
evaluating signs and symptoms of digoxin side effects and toxicity by using specific structured questions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02489786
Brief Title
A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital
Official Title
A Prospective Randomized Study of Different Digoxin Treatment Regimens in Egyptian Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Digoxin is a cardiac glycoside prescribed in heart failure and certain supraventricular tachyarrhythmias. It exerts a positive inotropic, neurohormonal, and electro physiologic actions on the heart . For heart failure patients, the targeted steady state serum digoxin level is between 0.5 and 0.8 ng/ml . Ventricular rate control in atrial fibrillation patients will usually require higher digoxin steady state serum concentrations . However, serum digoxin level higher than 2 ng/ml is associated with increased incidence of adverse drug reactions and should be avoided . Because of inter and intra-patient variability, narrow therapeutic index, and risk of toxicity, digoxin doses are calculated based on the patient weight, renal status, indications and drug interactions. Due to substantial overlap between therapeutic and toxic levels of digoxin, therapeutic drug monitoring is a must especially in patients with deteriorating renal function and electrolyte disturbance. In Egypt, most cardiologists give a digoxin holiday for patients with atrial fibrillation and /or heart failure where patients skip the drug doses on Thursday and Friday or Friday only every week to avoid possible drug accumulation and toxicity. It is not clear if these interrupted digoxin regimens really offer safer alternative over the continuous dosing regimens without compromising the effectiveness. It is anticipated that plasma digoxin levels may fall below the therapeutic range during the holiday which may affect patient clinical status and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regimen 1
Arm Type
Active Comparator
Arm Description
patient takes 0.25mg of digoxin daily except friday
Arm Title
Regimen 2
Arm Type
Active Comparator
Arm Description
patient takes 0.25mg of digoxin daily except Thursday and Friday
Arm Title
Regimen 3
Arm Type
Active Comparator
Arm Description
patient takes 0.125mg of digoxin daily
Arm Title
Regimen 4
Arm Type
Active Comparator
Arm Description
digoxin dose is calculated using Jusko-Koup method and given daily
Intervention Type
Drug
Intervention Name(s)
patients take 0.25 mg of digoxin daily except friday
Intervention Type
Drug
Intervention Name(s)
patients take 0.25 mg of digoxin daily except thursday and friday
Intervention Type
Drug
Intervention Name(s)
patients take 0.125 mg of digoxin daily
Intervention Type
Drug
Intervention Name(s)
digoxin dose is calculated using Jusko-Koup method and given daily
Primary Outcome Measure Information:
Title
measuring digoxin trough steady state plasma concentrations for the interrupted and continuous treatment regimens
Time Frame
1 month
Secondary Outcome Measure Information:
Title
evaluating patients quality of life using quality of life questionnaire for atrial fibrillation patients
Time Frame
1 month
Title
evaluating signs and symptoms of digoxin side effects and toxicity by using specific structured questions
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with atrial fibrillation (AF)
with or without congestive heart failure (CHF)
taking digoxin tablets with or without holiday regimens
Exclusion Criteria:
taking the following drugs concurrently: amiodarone, verapamil, quinidine and propafenone.
diagnosed with thyroid disorders (hyperthyroidism & hypothyroidism).
diagnosed with renal failure
pregnant
12. IPD Sharing Statement
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A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital
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