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Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands (DECISION)

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.
 
ClinicalTrials.gov Identifier: NCT03783429
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : December 12, 2023
Sponsor:
Collaborators:
Disphar International B.V.
Teva Nederland BV
Tiofarma BV
Netherlands Heart Foundation
Werkgroep Cardiologische centra Nederland
Information provided by (Responsible Party):
M. Rienstra, University Medical Center Groningen

Tracking Information
First Submitted Date  ICMJE December 13, 2018
First Posted Date  ICMJE December 21, 2018
Last Update Posted Date December 12, 2023
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2022)		 Composite of repeated HF hospitalizations, urgent HF Visits, and cardiovascular death [ Time Frame: Median of 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)		 Composite of repeated HF hospitalizations and cardiovascular death [ Time Frame: Median of 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2022)
  • All-cause mortality [ Time Frame: Median of 3 years ]
  • Cardiovascular death [ Time Frame: Median of 3 years ]
  • (Repeated) HF hospitalization [ Time Frame: Median of 3 years ]
  • Cost-effectiveness assessed by the Medical Consumption Questionnaire [ Time Frame: Median of 3 years ]
  • Urgent HF hospital visits [ Time Frame: Median of 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • All-cause mortality [ Time Frame: Median of 3 years ]
  • Cardiovascular death [ Time Frame: Median of 3 years ]
  • (Repeated) HF hospitalization [ Time Frame: Median of 3 years ]
  • Cost-effectiveness assessed by the Medical Consumption Questionnaire [ Time Frame: Median of 3 years ]
Current Other Pre-specified Outcome Measures
 (submitted: December 20, 2018)
  • All-cause hospitalizations [ Time Frame: Median of 3 years ]
  • Unscheduled cardiovascular hospital visits [ Time Frame: Median of 3 years ]
  • Days alive out of hospital [ Time Frame: Median of 3 years ]
  • 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.
  • Heart rate in both AF and sinus rhythm [ Time Frame: Median of 3 years ]
  • To assess side effects (SUSARs) associated with study medication [ Time Frame: Median of 3 years ]
  • Initiation of (recurrence of) AF in patients with sinus rhythm at baseline [ Time Frame: Median of 3 years ]
  • Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline [ Time Frame: Median of 3 years ]
Original Other Pre-specified Outcome Measures
 (submitted: December 18, 2018)
  • All-cause hospitalizations [ Time Frame: Median of 3 years ]
  • Unscheduled cardiovascular hospital visits [ Time Frame: Median of 3 years ]
  • Days alive out of hospital [ Time Frame: Median of 3 years ]
  • Quality of Life assessed by the EUROQOL-5D-5L questionnaire [ Time Frame: Median of 3 years ]
  • Heart rate in both AF and sinus rhythm [ Time Frame: Median of 3 years ]
  • To assess side effects (SUSARs) associated with study medication [ Time Frame: Median of 3 years ]
  • Initiation of (recurrence of) AF in patients with sinus rhythm at baseline [ Time Frame: Median of 3 years ]
  • Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline [ Time Frame: Median of 3 years ]
 
Descriptive Information
Brief Title  ICMJE Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Official Title  ICMJE Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Brief Summary 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%).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A national, multicenter, randomized, double-blind placebo controlled, clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind, placebo controlled
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Digoxin
    Digoxin tablets will be given orally
  • Drug: Placebos
    Placebo tablets will be given orally
Study Arms  ICMJE
  • Active Comparator: Intervention group
    The intervention group will receive low-dose digoxin
    Intervention: Drug: Digoxin
  • Placebo Comparator: Placebo group
    The placebo group will receive a matching placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 18, 2018)		 982
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥18year
  2. Outpatients with chronic HF, New York Heart Association [NYHA] class II - ambulatory IV
  3. LVEF<50%

  4. 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.

  5. ≥14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)

Exclusion Criteria:

  1. Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF)
  2. History of HF hospitalization ≤7days
  3. History of myocardial infarction, myocarditis, percutaneous intervention, RCT, pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days
  4. Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2
  5. The presence of a mechanical assist device
  6. Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)
  7. Scheduled for mechanical assist device or heart transplant
  8. Other non-cardiac conditions with limited life expectancy (≤ duration of the study)
  9. Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
  10. Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome)
  11. (Intermittent) complete heart block or second-degree AV block type Mobitz without pace maker or ICD
  12. Severe (grade III/III) aortic valve disease
  13. Complex congenital heart disease
  14. Proven hypersensitivity to digoxin (prior side effects)
  15. Concomitant medication that interacts with digoxin
  16. Use of digoxin ≤6 months prior to inclusion
  17. Participation in another (intervention) clinical trial (registry studies not included)
  18. Women who are pregnant, breastfeeding or may be considering pregnancy during the study period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03783429
Other Study ID Numbers  ICMJE DECISION trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party M. Rienstra, University Medical Center Groningen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Medical Center Groningen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Disphar International B.V.
  • Teva Nederland BV
  • Tiofarma BV
  • Netherlands Heart Foundation
  • Werkgroep Cardiologische centra Nederland
Investigators  ICMJE
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
PRS Account University Medical Center Groningen
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP