Intensive Versus Conventional Digoxin Use in Patients With Heart Failure (ICHF)
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02797145
|Contact: Andre R Duraes, PhDemail@example.com|
|Hospital ana Nery||Recruiting|
|Salvador, Bahia, Brazil, 40320010|
|Contact: Andre R Duraes, PhD +5571991888399 firstname.lastname@example.org|