Status:
COMPLETED
Digoxin Withdrawal in Stable Heart Failure
Lead Sponsor:
The Alfred
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure is a chronic condition in which the heart fails to function as a pump to move blood around the body. This sets up a complex physiologic response to compensate, which include activation o...
Eligibility Criteria
Inclusion
- Over the age of 18 years
- In sinus rhythm at the time of randomisation
- Have a LVEF \<0.45 and a left ventricular end-diastolic dimension \>60 mm or \>34 mm/m2
- Are receiving ACE inhibitor, β-blocker and diuretic therapy at the optimal doses.
- Has been receiving digoxin therapy for at least 3 months at a dose that results in digoxin plasma levels of 0.4-0.8 on 2 consecutive blood tests (at least 1 weeks apart) prior to randomisation. The dose of digoxin must remain stable for at least 2 weeks prior to randomisation.
- Documented, stable heart failure. Must have at least 1 of the following:
- Hospitalised with a discharge diagnosed of heart failure in the last 6 months
- Evidence of pulmonary congestion on chest X-ray
- Evidence of heart failure on echocardiogram
- Evidence of heart failure on ECG
- Willing and able to provide informed consent
Exclusion
- Systolic BP \>160mmHg or \<90mmHg
- Diastolic BP \>95mmHg
- Uncorrected primary valvular disease
- Active myocarditis
- Obstructive or restrictive Cardiomyopathy
- Exercise capacity limited by other factors not including dyspnoea
- Myocardial infarction within the previous 6 months
- Stroke within the previous 12 months
- Hospitalisation within one month of randomisation
- A history of supraventricular arrhythmia or sustained ventricular arrhythmia
- Claudication
- Severe primary pulmonary (VC \<1.5L), renal or hepatic disease
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01398371
Start Date
August 1 2011
End Date
June 1 2015
Last Update
June 1 2016
Active Locations (1)
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1
Clinical Pharmacology, Alfred Hospital
Melbourne, Victoria, Australia, 3004