Back to resultsDigoxin Withdrawal in Stable Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Withdrawal of digoxin
Digoxin
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Digoxin withdrawal
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Clinical Pharmacology, Alfred Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Stable digoxin therapy
Digoxin withdrawal
Arm Description
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.
Participants will receive a placebo for 4 weeks.
Outcomes
Primary Outcome Measures
NYHA Heart Failure class
Secondary Outcome Measures
6 minute walk test
Quality of Life
Standard questionnaires will be used
Change in BNP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01398371
Brief Title
Digoxin Withdrawal in Stable Heart Failure
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Alfred
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Digoxin withdrawal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stable digoxin therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Digoxin withdrawal
Arm Type
Experimental
Arm Description
Participants will receive a placebo for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Withdrawal of digoxin
Intervention Description
Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
Primary Outcome Measure Information:
Title
NYHA Heart Failure class
Time Frame
after 12 wks of treatment
Secondary Outcome Measure Information:
Title
6 minute walk test
Time Frame
after 12 wks of treatment
Title
Quality of Life
Description
Standard questionnaires will be used
Time Frame
After 12 weeks of treatment
Title
Change in BNP
Time Frame
After 12 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Krum, MBBS, FRACP, PhD
Organizational Affiliation
Alfred Hospital / Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Pharmacology, Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
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Digoxin Withdrawal in Stable Heart Failure
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