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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01398371




Registration number
NCT01398371
Ethics application status
Date submitted
19/07/2011
Date registered
20/07/2011
Date last updated
1/06/2016

Titles & IDs
Public title
Digoxin Withdrawal in Stable Heart Failure
Scientific title
A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy
Secondary ID [1] 0 0
Pending
Secondary ID [2] 0 0
257/11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Withdrawal of digoxin
Treatment: Drugs - Digoxin

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.

Experimental: Digoxin withdrawal - Participants will receive a placebo for 4 weeks.


Treatment: Drugs: Withdrawal of digoxin
Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.

Treatment: Drugs: Digoxin
Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
NYHA Heart Failure class
Timepoint [1] 0 0
after 12 wks of treatment
Secondary outcome [1] 0 0
6 minute walk test
Timepoint [1] 0 0
after 12 wks of treatment
Secondary outcome [2] 0 0
Quality of Life
Timepoint [2] 0 0
After 12 weeks of treatment
Secondary outcome [3] 0 0
Change in BNP
Timepoint [3] 0 0
After 12 weeks of treatment

Eligibility
Key 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, ß-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

7. Willing and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Clinical Pharmacology, Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01398371
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS, FRACP, PhD
Address 0 0
Alfred Hospital / Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01398371