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Intensive Versus Conventional Digoxin Use in Patients With Heart Failure (ICHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02797145
Recruitment Status : Unknown
Verified June 2016 by Andre Duraes, PhD, Hospital Ana Nery.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Information provided by (Responsible Party):
Andre Duraes, PhD, Hospital Ana Nery

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Digoxin dose-adjusted Drug: Standard dose Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Versus Conventional Digoxin Use in Patients With Heart Failure: a Randomized Controlled Trial
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Digoxin

Arm Intervention/treatment
Active Comparator: Intensive Group
Dose adjusted digoxin by the recommended range for the serum digoxin: 0.5-0.9 nanogram/mL
Drug: Digoxin dose-adjusted
Serum digoxin concentration : 0.5 to 0.9 nanogram/mL
Other Name: Intensive Digoxin

Placebo Comparator: Conventional
Use digoxin as recommended by the guidelines.
Drug: Standard dose
the dose of digoxin will be determined at the physician's discretion using traditional dosing methods.
Other Name: Conventional dose

Primary Outcome Measures :
  1. Proportion of patients with improvement in functional class and free of hospital admissions [ Time Frame: one year ]
    Digoxin can still be useful in people who remain symptomatic despite proper diuretic and ACE inhibitor treatment.

  2. Proportion of patients with adverse events: loss of appetite, nausea, vomiting, abdominal pain, diarrhea, blurred vision and or new atrial or ventricular extrasystoles. [ Time Frame: one year ]
    Common adverse effects (≥1% of patients) include loss of appetite, nausea, vomiting, and diarrhea as gastrointestinal motility increases.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02797145

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Contact: Andre R Duraes, PhD +5571991888399

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Hospital ana Nery Recruiting
Salvador, Bahia, Brazil, 40320010
Contact: Andre R Duraes, PhD    +5571991888399   
Sponsors and Collaborators
Hospital Ana Nery
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Responsible Party: Andre Duraes, PhD, Coordinator, Hospital Ana Nery Identifier: NCT02797145    
Other Study ID Numbers: 52553116.7.0000.0045
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Andre Duraes, PhD, Hospital Ana Nery:
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs