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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 1, 2015
    Last Updated
    July 3, 2015
    Sponsor
    Cairo University
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    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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