Digoxin Withdrawal in Stable Heart Failure

NCT01398371 | Completed

• 2 other identifiers: 257/11Pending
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure

Keywords

Heart failure; Digoxin withdrawal

Outcome Measures

Primary Outcomes (1)

• NYHA Heart Failure class

  after 12 wks of treatment

Secondary Outcomes (3)

• 6 minute walk test

  after 12 wks of treatment

• Quality of Life

  After 12 weeks of treatment

• Change in BNP

  After 12 weeks of treatment

Study Arms (2)

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.

Drug: Digoxin

Digoxin withdrawal

EXPERIMENTAL

Participants will receive a placebo for 4 weeks.

Drug: Withdrawal of digoxin

Interventions

Withdrawal of digoxin DRUG

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

Digoxin withdrawal

Digoxin DRUG

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

Stable digoxin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead

Study Sites (1)

Clinical Pharmacology, Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Digoxin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Henry Krum, MBBS, FRACP, PhD

  Alfred Hospital / Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ingrid Hopper

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 20, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

AU (1)