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A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02489786
Enrollment
71
Registered
2015-07-03
Start date
2012-10-31
Completion date
2014-10-31
Last updated
2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DRUGpatients take 0.25 mg of digoxin daily except friday
DRUGpatients take 0.25 mg of digoxin daily except thursday and friday
DRUGpatients take 0.125 mg of digoxin daily
DRUGdigoxin dose is calculated using Jusko-Koup method and given daily

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
measuring digoxin trough steady state plasma concentrations for the interrupted and continuous treatment regimens1 month

Secondary

MeasureTime frame
evaluating patients quality of life using quality of life questionnaire for atrial fibrillation patients1 month
evaluating signs and symptoms of digoxin side effects and toxicity by using specific structured questions1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026