- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03783429
Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands (DECISION)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Michiel Rienstra, MD, PhD
- Phone Number: +31-50-361-1327
- Email: m.rienstra@umcg.nl
Study Locations
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-
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Alkmaar, Netherlands
- Noordwest Ziekenhuisgroep
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Almelo, Netherlands
- Zorggroep Twente
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Amersfoort, Netherlands
- Meander Medisch Centrum
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Amsterdam, Netherlands
- BovenIJ Ziekenhuis
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Apeldoorn, Netherlands
- Gelre Ziekenhuizen
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Arnhem, Netherlands
- Rijnstate Ziekenhuis
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Beverwijk, Netherlands
- Rode Kruis Ziekenhuis
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Blaricum, Netherlands
- Tergooi
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Breda, Netherlands
- Amphia ziekenhuis
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Capelle Aan Den IJssel, Netherlands
- IJsselland Ziekenhuis
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Delft, Netherlands
- Reinier de Graaf Gasthuis
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Den Haag, Netherlands
- Haaglanden Medisch Centrum
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Deventer, Netherlands
- Deventer Ziekenhuis
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Dirksland, Netherlands
- Van Weel Bethesda
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Doetinchem, Netherlands
- Slingeland Ziekenhuis
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Ede, Netherlands
- Ziekenhuis Gelderse Vallei
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Emmen, Netherlands
- Scheper Ziekenhuis
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Goes, Netherlands
- Admiraal de Ruyter Ziekenhuis
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Gorinchem, Netherlands
- Beatrix Ziekenhuis
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Gouda, Netherlands
- Groene Hart Ziekenhuis
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Groningen, Netherlands
- Martini Ziekenhuis
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Groningen, Netherlands
- University Medical Center Groningen
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Haarlem, Netherlands
- Spaarne Gasthuis
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Hardenberg, Netherlands
- Saxenburgh MC
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Harderwijk, Netherlands
- Ziekenhuis St Jansdal
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Heerlen, Netherlands
- Zuyderland Medisch Centrum
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Helmond, Netherlands
- Elkerliek Ziekenhuis
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Hoogeveen, Netherlands
- Bethesda
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Leeuwarden, Netherlands
- Medisch Centrum Leeuwarden
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Leiden, Netherlands
- Alrijne Ziekenhuis
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Maastricht, Netherlands
- Maastricht UMC+
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Meppel, Netherlands
- Isala Diaconessenhuis
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Nijmegen, Netherlands
- Radboud University Medical Center
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Roosendaal, Netherlands
- Bravis Ziekenhuis
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Rotterdam, Netherlands
- Erasmus Medisch Centrum
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Rotterdam, Netherlands
- Ikazia Ziekenhuis
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Rotterdam, Netherlands
- Franciscus Gasthuis
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Schiedam, Netherlands
- Franciscus Vlietland
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Sneek, Netherlands
- Antonius Ziekenhuis Sneek
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Stadskanaal, Netherlands
- Refaja
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Tilburg, Netherlands
- Elisabeth-TweeSteden Ziekenhuis
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Utrecht, Netherlands
- Diak. Utrecht
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Veldhoven, Netherlands
- Maxima Medisch Centrum
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Zaandam, Netherlands
- Zaans Medisch Centrum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18year
- Outpatients with chronic HF, New York Heart Association [NYHA] class II - ambulatory IV
- LVEF<50%
Serum NT-proBNP concentrations:
Previous HF hospitalization ≤ 1 year before randomisation ≥400pg/mL if sinus rhythm; ≥800pg/mL if AF Previous HF hospitalization > 1 year before randomisation or in the absence of HF hospitalizations ≥ 600pg/mL if sinus rhythm; ≥1000 pg/mL if AF
BNP concentrations:
Previous HF hospitalization ≤ 1 year before randomisation ≥100pg/mL if sinus rhythm; ≥200pg/mL if AF Previous HF hospitalization > 1 year before randomisation or in absence of HF hospitalization ≥150pg/mL if sinus rhythm; ≥250pg/mL if AF.
- ≥14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)
Exclusion Criteria:
- Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF)
- History of HF hospitalization ≤7days
- History of myocardial infarction, myocarditis, percutaneous intervention, RCT, pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days
- Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2
- The presence of a mechanical assist device
- Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)
- Scheduled for mechanical assist device or heart transplant
- Other non-cardiac conditions with limited life expectancy (≤ duration of the study)
- Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
- Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome)
- (Intermittent) complete heart block or second-degree AV block type Mobitz without pace maker or ICD
- Severe (grade III/III) aortic valve disease
- Complex congenital heart disease
- Proven hypersensitivity to digoxin (prior side effects)
- Concomitant medication that interacts with digoxin
- Use of digoxin ≤6 months prior to inclusion
- Participation in another (intervention) clinical trial (registry studies not included)
- Women who are pregnant, breastfeeding or may be considering pregnancy during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention group
The intervention group will receive low-dose digoxin
|
Digoxin tablets will be given orally
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Placebo Comparator: Placebo group
The placebo group will receive a matching placebo
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Placebo tablets will be given orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of repeated HF hospitalizations, urgent HF Visits, and cardiovascular death
Time Frame: Median of 3 years
|
Median of 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: Median of 3 years
|
Median of 3 years
|
Cardiovascular death
Time Frame: Median of 3 years
|
Median of 3 years
|
(Repeated) HF hospitalization
Time Frame: Median of 3 years
|
Median of 3 years
|
Cost-effectiveness assessed by the Medical Consumption Questionnaire
Time Frame: Median of 3 years
|
Median of 3 years
|
Urgent HF hospital visits
Time Frame: Median of 3 years
|
Median of 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause hospitalizations
Time Frame: Median of 3 years
|
Median of 3 years
|
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Unscheduled cardiovascular hospital visits
Time Frame: Median of 3 years
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Median of 3 years
|
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Days alive out of hospital
Time Frame: Median of 3 years
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Median of 3 years
|
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Quality of Life assessed by the EUROQOL-5D-5L questionnaire
Time Frame: Median of 3 years
|
Quality of Life is assessed by questions about mobility, selfcare, daily activity, pain and anxiety. The questions about mobility, selfcare and daily activity range from 'no problem doing activity' to 'not able to do activity'. The questions about pain and anxiety range from 'not at all present' to 'extremely present'. The last question in the questionnaire asks how a person rates his or her health in the present day, ranging from 0-100, where 0 is the worst health imaginable, and 100 is the best health imaginable. |
Median of 3 years
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Heart rate in both AF and sinus rhythm
Time Frame: Median of 3 years
|
Median of 3 years
|
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To assess side effects (SUSARs) associated with study medication
Time Frame: Median of 3 years
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Median of 3 years
|
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Initiation of (recurrence of) AF in patients with sinus rhythm at baseline
Time Frame: Median of 3 years
|
Median of 3 years
|
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Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline
Time Frame: Median of 3 years
|
Median of 3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michiel Rienstra, MD, PhD, University Medical Center Groningen
- Principal Investigator: Peter van der Meer, MD, PhD, University Medical Center Groningen
- Principal Investigator: Dirk J van Veldhuisen, MD, PhD, University Medical Center Groningen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DECISION trial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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