Heart FailureNCT01398371
Digoxin Withdrawal in Stable Heart Failure
A study testing Withdrawal of digoxin and Digoxin in people with Heart Failure, run by The Alfred at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Withdrawal of digoxin and Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Clinical Pharmacology, Alfred Hospital
Melbourne, Victoria, 3004
About this study
Official title: A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy
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.
Read more
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
- Being tested
- Withdrawal of digoxin, Digoxin
- Keywords
- Heart failure, Digoxin withdrawal
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of digoxinDrug
Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.
DigoxinDrug
Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
| Study group | Role | What they receive |
|---|---|---|
| Stable digoxin therapy | Active comparator | 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. Receives: Drug: Digoxin |
| Digoxin withdrawal | Experimental | Participants will receive a placebo for 4 weeks. Receives: Drug: Withdrawal of digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NYHA Heart Failure class
Measured: after 12 wks of treatment
Secondary outcomes (3)
6 minute walk test
Measured: after 12 wks of treatment
Quality of Life
Standard questionnaires will be used
Measured: After 12 weeks of treatment
Change in BNP
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Hopper, The Alfred
- Investigators
- Henry Krum, MBBS, FRACP, PhD, Principal investigator, Alfred Hospital / Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398371
- Sponsor's protocol ID
- 257/11
- Other IDs
- Pending
- Status last verified
- May 2016
- First submitted
- 19 Jul 2011
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy
- ClinicalTrials.gov ID
- NCT01398371
- Acronym / sponsor ID
- 257/11
- Conditions
- Heart Failure
- Keywords
- Heart failure, Digoxin withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable digoxin therapy | Active comparator | Drug: DigoxinParticipants 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. |
| Digoxin withdrawal | Experimental | Drug: Withdrawal of digoxinParticipants will receive a placebo for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- Systolic BP >160mmHg or <90mmHg
- Diastolic BP >95mmHg
- Uncorrected primary valvular disease
- Active myocarditis
- Obstructive or restrictive Cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of digoxinParticipants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks. | Drug | Digoxin withdrawal |
| DigoxinStable digoxin therapy which produces a digoxin plasma level of 0.4-0.8. | Drug | Stable digoxin therapy |
Primary outcome
NYHA Heart Failure class
Time frame: after 12 wks of treatment
3 secondary outcomes
6 minute walk test
Time frame: after 12 wks of treatment
Quality of Life
Time frame: After 12 weeks of treatment
Change in BNP
Time frame: After 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
Related trials for Heart Failure
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Heart Failure and Aortic Stenosis Transcriptome
Heart Failure, Aortic Stenosis
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Krum, MBBS, FRACP, PhD principal investigator
Alfred Hospital / Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withdrawal of digoxin and Digoxin in people with Heart Failure, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NYHA Heart Failure class (time frame: after 12 wks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.