This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Digoxin Withdrawal in Stable Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ingrid Hopper, The Alfred
ClinicalTrials.gov Identifier:
NCT01398371
First received: July 19, 2011
Last updated: May 30, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Heart Failure Drug: Withdrawal of digoxin Drug: Digoxin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy

Resource links provided by NLM:


Further study details as provided by Ingrid Hopper, The Alfred:

Primary Outcome Measures:
  • NYHA Heart Failure class [ Time Frame: after 12 wks of treatment ]

Secondary Outcome Measures:
  • 6 minute walk test [ Time Frame: after 12 wks of treatment ]
  • Quality of Life [ Time Frame: After 12 weeks of treatment ]
    Standard questionnaires will be used

  • Change in BNP [ Time Frame: After 12 weeks of treatment ]

Enrollment: 16
Study Start Date: August 2011
Study Completion Date: June 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Digoxin
Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
Experimental: Digoxin withdrawal
Participants will receive a placebo for 4 weeks.
Drug: Withdrawal of digoxin
Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398371

Locations
Australia, Victoria
Clinical Pharmacology, Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
Investigators
Principal Investigator: Henry Krum, MBBS, FRACP, PhD Alfred Hospital / Monash University
  More Information

Responsible Party: Ingrid Hopper, Dr Ingrid Hopper, The Alfred
ClinicalTrials.gov Identifier: NCT01398371     History of Changes
Other Study ID Numbers: 257/11
Pending ( Other Grant/Funding Number: Pending )
Study First Received: July 19, 2011
Last Updated: May 30, 2016

Keywords provided by Ingrid Hopper, The Alfred:
Heart failure
Digoxin withdrawal

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017