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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

Study Description
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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%).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Digoxin Drug: Placebos Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 982 participants
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
Official Title: Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention group
The intervention group will receive low-dose digoxin
 Drug: Digoxin
Digoxin tablets will be given orally
Placebo Comparator: Placebo group
The placebo group will receive a matching placebo
 Drug: Placebos
Placebo tablets will be given orally


Outcome Measures
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Primary Outcome Measures :
  1. Composite of repeated HF hospitalizations, urgent HF Visits, and cardiovascular death [ Time Frame: Median of 3 years ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Median of 3 years ]
  2. Cardiovascular death [ Time Frame: Median of 3 years ]
  3. (Repeated) HF hospitalization [ Time Frame: Median of 3 years ]
  4. Cost-effectiveness assessed by the Medical Consumption Questionnaire [ Time Frame: Median of 3 years ]
  5. Urgent HF hospital visits [ Time Frame: Median of 3 years ]

Other Outcome Measures:
  1. All-cause hospitalizations [ Time Frame: Median of 3 years ]
  2. Unscheduled cardiovascular hospital visits [ Time Frame: Median of 3 years ]
  3. Days alive out of hospital [ Time Frame: Median of 3 years ]
  4. 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.


  5. Heart rate in both AF and sinus rhythm [ Time Frame: Median of 3 years ]
  6. To assess side effects (SUSARs) associated with study medication [ Time Frame: Median of 3 years ]
  7. Initiation of (recurrence of) AF in patients with sinus rhythm at baseline [ Time Frame: Median of 3 years ]
  8. Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline [ Time Frame: Median of 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03783429


Locations
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Sponsors and Collaborators
University Medical Center Groningen
Disphar International B.V.
Teva Nederland BV
Tiofarma BV
Netherlands Heart Foundation
Werkgroep Cardiologische centra Nederland
Investigators
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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
More Information
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Responsible Party: M. Rienstra, Prof. Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03783429    
Other Study ID Numbers: DECISION trial
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023

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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
Keywords provided by M. Rienstra, University Medical Center Groningen:
Heart Failure
Digoxin
Atrial fibrillation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Digoxin
Anti-Arrhythmia Agents
 Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs