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| ID | Type | Description | Link |
|---|---|---|---|
| Pending | Other Grant/Funding Number | Pending |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Digoxin withdrawal | Experimental | Participants will receive a placebo for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Withdrawal of digoxin | Drug | Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NYHA Heart Failure class | after 12 wks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk test | after 12 wks of treatment | |
| Quality of Life | Standard questionnaires will be used | After 12 weeks of treatment |
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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:
Willing and able to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Krum, MBBS, FRACP, PhD | Alfred Hospital / Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology, Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8. |
|
| Change in BNP |
| After 12 weeks of treatment |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |