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Completed

NCT Number: NCT02489786

A Prospective 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. measuring digoxin trough steady state plasma concentrations for the interrupted and continuous treatment regimens

    Time frame: 1 month

Secondary outcomes

  1. evaluating patients quality of life using quality of life questionnaire for atrial fibrillation patients

    Time frame: 1 month

  2. evaluating signs and symptoms of digoxin side effects and toxicity by using specific structured questions

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2015
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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