Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01005602
Eligibility Criteria:
Inclusion Criteria:
* Age \> 21 years
* Diagnosis of heart failure secondary to left ventricular dysfunction
* Receiving chronic digoxin therapy or digoxin therapy is being initiated
Exclusion Criteria:
* Pregnant
* Unstable renal function, defined as either a rise in serum creatinine by \> 0.5mg/dl from baseline or a decrease in creatinine clearance by 25% or more within two to four weeks of study entry.
* End-stage renal disease requiring hemodialysis
* Concomitant therapy with drugs known to interact with digoxin (e.g., amiodarone, quinidine, verapamil, macrolide antibiotics)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT01005602
Study Brief:
Protocol Section:
NCT01005602