NCT01398371

Digoxin Withdrawal in Stable Heart Failure

A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: The Alfred · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Withdrawal of digoxin	Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.
DRUG	Digoxin	Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-02-01
• Completion: 2015-06-01
• First posted: 2011-07-20
• Last updated: 2016-06-01

Locations

1 site across 1 country: Australia