Digoxin Withdrawal in Stable Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Alfred
Sponsor:
Information provided by (Responsible Party):
Henry Krum, The Alfred
ClinicalTrials.gov Identifier:
NCT01398371
First received: July 19, 2011
Last updated: May 29, 2013
Last verified: May 2013

July 19, 2011
May 29, 2013
August 2011
December 2015   (final data collection date for primary outcome measure)
NYHA Heart Failure class [ Time Frame: after 12 wks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01398371 on ClinicalTrials.gov Archive Site
  • 6 minute walk test [ Time Frame: after 12 wks of treatment ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Standard questionnaires will be used
  • Change in BNP [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Digoxin Withdrawal in Stable Heart Failure
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Heart Failure
  • Drug: Withdrawal of digoxin
    Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.
  • Drug: Digoxin
    Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
  • 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.
    Intervention: Drug: Digoxin
  • Experimental: Digoxin withdrawal
    Participants will receive a placebo for 4 weeks.
    Intervention: Drug: Withdrawal of digoxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2015   (final data collection date for primary outcome measure)

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
  7. 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
Both
18 Years and older
No
Contact: Henry Krum, MBBS, FRACP, PhD +61 3 9903 0042 henry.krum@monash.edu
Contact: Ingrid Hopper, MBBS, FRACP +61 3 9076 8542 i.hopper@alfred.org.au
Australia
 
NCT01398371
257/11, Pending
No
Henry Krum, The Alfred
The Alfred
Not Provided
Principal Investigator: Henry Krum, MBBS, FRACP, PhD Alfred Hospital / Monash University
The Alfred
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP