Clinical Pharmacology, Alfred Hospital
Melbourne, Victoria, 3004, Australia
NCT Number: NCT01398371
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 of many hormonal mechanisms which result in fluid accumulation.
In recent years, medications to block the hormonal response to heart failure are given as standard drugs, and these include ACE inhibitors, and beta blockers. Mortality is reduced with these medications, as well as symptoms improved.
Medications that were traditionally used in heart failure include diuretics, which cause fluid loss, and digoxin, which causes the heart to pump harder. These medications were introduced before clinical trials as we know them now were run. Since the introduction of ACE inhibitors and beta blockers, it is not clear whether there is still a role for digoxin.
In this study, we plan to withdraw digoxin from patients with stable heart failure in normal rhythm, taking stable doses of ACE inhibitors and beta blockers, in a closely monitored environment and watch for the effect of this on heart failure.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Melbourne, Victoria, 3004, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.
Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
Time frame: after 12 wks of treatment
Time frame: after 12 wks of treatment
Time frame: After 12 weeks of treatment
Standard questionnaires will be used
Time frame: After 12 weeks of treatment
The Alfred
Other
A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy
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