<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03783429</url>
  </required_header>
  <id_info>
    <org_study_id>DECISION trial</org_study_id>
    <nct_id>NCT03783429</nct_id>
  </id_info>
  <brief_title>Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands</brief_title>
  <acronym>DECISION</acronym>
  <official_title>Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Disphar International B.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Teva Nederland BV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tiofarma BV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Netherlands Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Werkgroep Cardiologische centra Nederland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large&#xD;
      trial with digoxin, the DIG trial, executed in the early nineties revealed a highly&#xD;
      significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis&#xD;
      of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF&#xD;
      hospitalizations but also mortality in chronic HF patients. To confirm these retrospective&#xD;
      analyses, a prospective, randomized, placebo-controlled trial is necessary to establish the&#xD;
      position of digoxin in the contemporary treatment of HF. Therefore, the investigators examine&#xD;
      whether low-level, aiming for serum concentrations 0.5-0.9ng/mL, digoxin is beneficial in HF&#xD;
      patients with reduced or mid-range ejection fractions (LVEF &lt;50%).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A national, multicenter, randomized, double-blind placebo controlled, clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blind, placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of repeated HF hospitalizations, urgent HF Visits, and cardiovascular death</measure>
    <time_frame>Median of 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Median of 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>Median of 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(Repeated) HF hospitalization</measure>
    <time_frame>Median of 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness assessed by the Medical Consumption Questionnaire</measure>
    <time_frame>Median of 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urgent HF hospital visits</measure>
    <time_frame>Median of 3 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>All-cause hospitalizations</measure>
    <time_frame>Median of 3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Unscheduled cardiovascular hospital visits</measure>
    <time_frame>Median of 3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Days alive out of hospital</measure>
    <time_frame>Median of 3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life assessed by the EUROQOL-5D-5L questionnaire</measure>
    <time_frame>Median of 3 years</time_frame>
    <description>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'.&#xD;
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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate in both AF and sinus rhythm</measure>
    <time_frame>Median of 3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>To assess side effects (SUSARs) associated with study medication</measure>
    <time_frame>Median of 3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Initiation of (recurrence of) AF in patients with sinus rhythm at baseline</measure>
    <time_frame>Median of 3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline</measure>
    <time_frame>Median of 3 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">982</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention group will receive low-dose digoxin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will receive a matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin</intervention_name>
    <description>Digoxin tablets will be given orally</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo tablets will be given orally</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18year&#xD;
&#xD;
          2. Outpatients with chronic HF, New York Heart Association [NYHA] class II - ambulatory&#xD;
             IV&#xD;
&#xD;
          3. LVEF&lt;50%&#xD;
&#xD;
          4. Serum NT-proBNP concentrations:&#xD;
&#xD;
             Previous HF hospitalization ≤ 1 year before randomisation ≥400pg/mL if sinus rhythm;&#xD;
             ≥800pg/mL if AF Previous HF hospitalization &gt; 1 year before randomisation or in the&#xD;
             absence of HF hospitalizations ≥ 600pg/mL if sinus rhythm; ≥1000 pg/mL if AF&#xD;
&#xD;
             BNP concentrations:&#xD;
&#xD;
             Previous HF hospitalization ≤ 1 year before randomisation ≥100pg/mL if sinus rhythm;&#xD;
             ≥200pg/mL if AF Previous HF hospitalization &gt; 1 year before randomisation or in&#xD;
             absence of HF hospitalization ≥150pg/mL if sinus rhythm; ≥250pg/mL if AF.&#xD;
&#xD;
          5. ≥14 days stable on guideline-recommended therapy (doses and number of therapies as&#xD;
             tolerated by each patient)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF)&#xD;
&#xD;
          2. History of HF hospitalization ≤7days&#xD;
&#xD;
          3. History of myocardial infarction, myocarditis, percutaneous intervention, RCT,&#xD;
             pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days&#xD;
&#xD;
          4. Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2&#xD;
&#xD;
          5. The presence of a mechanical assist device&#xD;
&#xD;
          6. Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)&#xD;
&#xD;
          7. Scheduled for mechanical assist device or heart transplant&#xD;
&#xD;
          8. Other non-cardiac conditions with limited life expectancy (≤ duration of the study)&#xD;
&#xD;
          9. Amyloid, hypertrophic obstructive or constrictive cardiomyopathy&#xD;
&#xD;
         10. Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome)&#xD;
&#xD;
         11. (Intermittent) complete heart block or second-degree AV block type Mobitz without pace&#xD;
             maker or ICD&#xD;
&#xD;
         12. Severe (grade III/III) aortic valve disease&#xD;
&#xD;
         13. Complex congenital heart disease&#xD;
&#xD;
         14. Proven hypersensitivity to digoxin (prior side effects)&#xD;
&#xD;
         15. Concomitant medication that interacts with digoxin&#xD;
&#xD;
         16. Use of digoxin ≤6 months prior to inclusion&#xD;
&#xD;
         17. Participation in another (intervention) clinical trial (registry studies not included)&#xD;
&#xD;
         18. Women who are pregnant, breastfeeding or may be considering pregnancy during the study&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michiel Rienstra, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter van der Meer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dirk J van Veldhuisen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michiel Rienstra, MD, PhD</last_name>
    <phone>+31-50-361-1327</phone>
    <email>m.rienstra@umcg.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Noordwest Ziekenhuisgroep</name>
      <address>
        <city>Alkmaar</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zorggroep Twente</name>
      <address>
        <city>Almelo</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Meander Medisch Centrum</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BovenIJ Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Gelre Ziekenhuizen</name>
      <address>
        <city>Apeldoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rijnstate Ziekenhuis</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rode Kruis Ziekenhuis</name>
      <address>
        <city>Beverwijk</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tergooi</name>
      <address>
        <city>Blaricum</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ijsselland Ziekenhuis</name>
      <address>
        <city>Capelle Aan Den IJssel</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf Gasthuis</name>
      <address>
        <city>Delft</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Haaglanden Medisch Centrum</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Deventer Ziekenhuis</name>
      <address>
        <city>Deventer</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Van Weel Bethesda</name>
      <address>
        <city>Dirksland</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Slingeland Ziekenhuis</name>
      <address>
        <city>Doetinchem</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Scheper Ziekenhuis</name>
      <address>
        <city>Emmen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Admiraal de Ruyter Ziekenhuis</name>
      <address>
        <city>Goes</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beatrix Ziekenhuis</name>
      <address>
        <city>Gorinchem</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Groene Hart Ziekenhuis</name>
      <address>
        <city>Gouda</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Martini Ziekenhuis</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spaarne Gasthuis</name>
      <address>
        <city>Haarlem</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saxenburgh MC</name>
      <address>
        <city>Hardenberg</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis St Jansdal</name>
      <address>
        <city>Harderwijk</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medisch Centrum</name>
      <address>
        <city>Heerlen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Elkerliek Ziekenhuis</name>
      <address>
        <city>Helmond</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bethesda</name>
      <address>
        <city>Hoogeveen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alrijne Ziekenhuis</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maastricht UMC+</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Isala Diaconessenhuis</name>
      <address>
        <city>Meppel</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bravis ziekenhuis</name>
      <address>
        <city>Roosendaal</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Franciscus Gasthuis</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ikazia Ziekenhuis</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Franciscus Vlietland</name>
      <address>
        <city>Schiedam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Antonius Ziekenhuis Sneek</name>
      <address>
        <city>Sneek</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Refaja</name>
      <address>
        <city>Stadskanaal</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Elisabeth-Tweesteden Ziekenhuis</name>
      <address>
        <city>Tilburg</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Diak. Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Máxima Medisch Centrum</name>
      <address>
        <city>Veldhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zaans Medisch Centrum</name>
      <address>
        <city>Zaandam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>M. Rienstra</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Digoxin</keyword>
  <keyword>Atrial fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digoxin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03783429
org study id: DECISION trial
nct id: NCT03783429
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large
      trial with digoxin, the DIG trial, executed in the early nineties revealed a highly
      significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis
      of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF
      hospitalizations but also mortality in chronic HF patients. To confirm these retrospective
      analyses, a prospective, randomized, placebo-controlled trial is necessary to establish the
      position of digoxin in the contemporary treatment of HF. Therefore, the investigators examine
      whether low-level, aiming for serum concentrations 0.5-0.9ng/mL, digoxin is beneficial in HF
      patients with reduced or mid-range ejection fractions (LVEF <50%).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A national, multicenter, randomized, double-blind placebo controlled, clinical trial.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blind, placebo controlled
measure: Composite of repeated HF hospitalizations, urgent HF Visits, and cardiovascular death
time frame: Median of 3 years
measure: All-cause mortality
time frame: Median of 3 years
measure: Cardiovascular death
time frame: Median of 3 years
measure: (Repeated) HF hospitalization
time frame: Median of 3 years
measure: Cost-effectiveness assessed by the Medical Consumption Questionnaire
time frame: Median of 3 years
measure: Urgent HF hospital visits
time frame: Median of 3 years
measure: All-cause hospitalizations
time frame: Median of 3 years
measure: Unscheduled cardiovascular hospital visits
time frame: Median of 3 years
measure: Days alive out of hospital
time frame: Median of 3 years
measure: Quality of Life assessed by the EUROQOL-5D-5L questionnaire
time frame: Median of 3 years
description: 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.
measure: Heart rate in both AF and sinus rhythm
time frame: Median of 3 years
measure: To assess side effects (SUSARs) associated with study medication
time frame: Median of 3 years
measure: Initiation of (recurrence of) AF in patients with sinus rhythm at baseline
time frame: Median of 3 years
measure: Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline
time frame: Median of 3 years
arm group label: Intervention group
arm group type: Active Comparator
description: The intervention group will receive low-dose digoxin
arm group label: Placebo group
arm group type: Placebo Comparator
description: The placebo group will receive a matching placebo
intervention type: Drug
intervention name: Digoxin
description: Digoxin tablets will be given orally
arm group label: Intervention group
intervention type: Drug
intervention name: Placebos
description: Placebo tablets will be given orally
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michiel Rienstra, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
last name: Peter van der Meer, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
last name: Dirk J van Veldhuisen, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
last name: Michiel Rienstra, MD, PhD
phone: +31-50-361-1327
email: m.rienstra@umcg.nl
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: M. Rienstra
investigator title: Prof. Dr.
mesh term: Heart Failure
mesh term: Digoxin