Digoxin Withdrawal in Stable Heart Failure
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy|
- NYHA Heart Failure class [ Time Frame: after 12 wks of treatment ] [ Designated as safety issue: No ]
- 6 minute walk test [ Time Frame: after 12 wks of treatment ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]Standard questionnaires will be used
- Change in BNP [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Stable digoxin therapy
Participants need to have 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.
Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
Experimental: Digoxin withdrawal
Participants will receive a placebo for 4 weeks.
Drug: Withdrawal of digoxin
Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398371
|Contact: Henry Krum, MBBS, FRACP, PhD||+61 3 9903 firstname.lastname@example.org|
|Contact: Ingrid Hopper, MBBS, FRACP||+61 3 9076 email@example.com|
|Clinical Pharmacology, Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Henry Krum, MBBS, FRACP, PhD +61 3 9903 0042 firstname.lastname@example.org|
|Contact: Ingrid Hopper, MBBS, FRACP +61 3 9076 8542 email@example.com|
|Principal Investigator:||Henry Krum, MBBS, FRACP, PhD||Alfred Hospital / Monash University|