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Completed

NCT Number: NCT01398371

Digoxin Withdrawal in Stable Heart Failure

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Pharmacology, Alfred Hospital

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Withdrawal of digoxin

Drug

Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.

Digoxin

Drug

Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.

Primary outcomes

  1. NYHA Heart Failure class

    Time frame: after 12 wks of treatment

Secondary outcomes

  1. 6 minute walk test

    Time frame: after 12 wks of treatment

  2. Quality of Life

    Time frame: After 12 weeks of treatment

    Standard questionnaires will be used

  3. Change in BNP

    Time frame: After 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

The Alfred

Other

Registry information

Official study title

A Randomised, Blinded, Placebo Controlled Trial to Assess the Effect of Digoxin Withdrawal in Stable Heart Failure Patients Receiving Optimal Background Therapy

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2011
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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