Digoxin Withdrawal in Stable Heart Failure

• Sponsor: The Alfred (Other)
• Overall Status: Completed
• CT.gov ID: NCT01398371
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Withdrawal of digoxin; Drug: Digoxin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Digoxin; 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.

Outcome Measures

Primary Outcome Measures

1. NYHA Heart Failure class [after 12 wks of treatment]

Secondary Outcome Measures

1. 6 minute walk test [after 12 wks of treatment]

2. Quality of Life [After 12 weeks of treatment]

   Standard questionnaires will be used

3. Change in BNP [After 12 weeks of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Over the age of 18 years

2. In sinus rhythm at the time of randomisation

3. Have a LVEF <0.45 and a left ventricular end-diastolic dimension >60 mm or >34 mm/m2

4. Are receiving ACE inhibitor, β-blocker and diuretic therapy at the optimal doses.

5. 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.

6. 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

1. Willing and able to provide informed consent

Exclusion Criteria:

1. Systolic BP >160mmHg or <90mmHg

2. Diastolic BP >95mmHg

3. Uncorrected primary valvular disease

4. Active myocarditis

5. Obstructive or restrictive Cardiomyopathy

6. Exercise capacity limited by other factors not including dyspnoea

7. Myocardial infarction within the previous 6 months

8. Stroke within the previous 12 months

9. Hospitalisation within one month of randomisation

10. A history of supraventricular arrhythmia or sustained ventricular arrhythmia

11. Claudication

12. Severe primary pulmonary (VC <1.5L), renal or hepatic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology, Alfred Hospital	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

• The Alfred

Investigators

• Principal Investigator: Henry Krum, MBBS, FRACP, PhD, Alfred Hospital / Monash University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ingrid Hopper, Dr Ingrid Hopper, The Alfred
• ClinicalTrials.gov Identifier: NCT01398371
• Other Study ID Numbers: 257/11; Pending
• First Posted: Jul 20, 2011
• Last Update Posted: Jun 1, 2016
• Last Verified: May 1, 2016

• Keywords provided by Ingrid Hopper, Dr Ingrid Hopper, The Alfred: Heart failure; Digoxin withdrawal
• Additional relevant MeSH terms: Heart Failure; Digoxin

Study Results

No Results Posted as of Jun 1, 2016