A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital

A Prospective Randomized Study of Different Digoxin Treatment Regimens in Egyptian Hospital

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: patients take 0.25 mg of digoxin daily except friday; Drug: patients take 0.25 mg of digoxin daily except thursday and friday; Drug: patients take 0.125 mg of digoxin daily; Drug: digoxin dose is calculated using Jusko-Koup method and given daily

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Regimen 1; patient takes 0.25mg of digoxin daily except friday	Drug: patients take 0.25 mg of digoxin daily except friday
ACTIVE_COMPARATOR: Regimen 2; patient takes 0.25mg of digoxin daily except Thursday and Friday	Drug: patients take 0.25 mg of digoxin daily except thursday and friday
ACTIVE_COMPARATOR: Regimen 3; patient takes 0.125mg of digoxin daily	Drug: patients take 0.125 mg of digoxin daily
ACTIVE_COMPARATOR: Regimen 4; digoxin dose is calculated using Jusko-Koup method and given daily	Drug: digoxin dose is calculated using Jusko-Koup method and given daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measuring digoxin trough steady state plasma concentrations for the interrupted and continuous treatment regimens	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (ESTIMATE): July 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 3, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: CL (312)