Intensive Versus Conventional Digoxin Use in Patients With Heart Failure

NCT02797145 | Unknown Phase 2 DMC

• 1 other identifier: 52553116.7.0000.0045
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Digoxin was approved for heart failure treatment in 1998 according to current regulations made by Food and Drug Administration (FDA), based on the following clinical trials: The Prospective and Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED), Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme (RADIANCE) and Digitalis Investigation Group (DIG). Also, it was approved for the control of ventricular response rate in atrial fibrillation patients. Several clinical trials with digoxin provided convincing evidence that support the digoxin use heart failure (HF) treatment of symptomatic patients. PROVED trial was a placebo-controlled, twelve weeks duration study. This study included patients with decreased systolic function, sinus rhythm and heart failure stable symptoms, these patients were using digoxin and diuretics. Patients whom digoxin was removed presented a twice heart failure worsen, reduction of exercise capacity and also a reduction of left ventricle ejection fraction, in comparison to patients that kept the digoxin therapy. The study RADIANCE followed a similar protocol; however the patients used ACE inhibitors besides digoxin and diuretics. The digoxin removal was associated with a six times worsen of heart failure, despite the maintenance of ACE inhibitors and diuretics. There was a worsening in the functional capacity, life quality and in the ejection fraction on the digoxin removal patients' group.

Conditions

Heart Failure

Keywords

Digoxin

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with improvement in functional class and free of hospital admissions

  Digoxin can still be useful in people who remain symptomatic despite proper diuretic and ACE inhibitor treatment.

  one year

• Proportion of patients with adverse events: loss of appetite, nausea, vomiting, abdominal pain, diarrhea, blurred vision and or new atrial or ventricular extrasystoles.

  Common adverse effects (≥1% of patients) include loss of appetite, nausea, vomiting, and diarrhea as gastrointestinal motility increases.

  one year

Study Arms (2)

Intensive Group

ACTIVE COMPARATOR

Dose adjusted digoxin by the recommended range for the serum digoxin: 0.5-0.9 nanogram/mL

Drug: Digoxin dose-adjusted

Conventional

PLACEBO COMPARATOR

Use digoxin as recommended by the guidelines.

Drug: Standard dose

Interventions

Digoxin dose-adjusted DRUG

Serum digoxin concentration : 0.5 to 0.9 nanogram/mL

Also known as: Intensive Digoxin

Intensive Group

Standard dose DRUG

the dose of digoxin will be determined at the physician's discretion using traditional dosing methods.

Also known as: Conventional dose

Conventional

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart Failure with reduced EF (\< 40%) and sinusal rhythm or atrial fibrillation

You may not qualify if:

• Pregnant women
• Any degree of atrioventricular block
• Renal failure (Creatinine Clearance lower than 50 mL/min)

Sponsors & Collaborators

• Hospital Ana Nery: lead

Study Sites (1)

Hospital ana Nery

Salvador, Estado de Bahia, 40320010, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Andre R Duraes, PhD

CONTACT

+5571991888399; andreduraes@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 13, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

BR (1)