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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Digoxin
Placebos
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Digoxin, Atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Noordwest Ziekenhuisgroep
  • Zorggroep TwenteRecruiting
  • Meander Medisch CentrumRecruiting
  • BovenIJ ZiekenhuisRecruiting
  • Onze Lieve Vrouwe Gasthuis
  • Gelre ZiekenhuizenRecruiting
  • Rijnstate ZiekenhuisRecruiting
  • Rode Kruis ZiekenhuisRecruiting
  • TergooiRecruiting
  • Amphia ZiekenhuisRecruiting
  • Ijsselland ZiekenhuisRecruiting
  • Reinier de Graaf GasthuisRecruiting
  • Haaglanden Medisch CentrumRecruiting
  • Deventer ZiekenhuisRecruiting
  • Van Weel Bethesda
  • Slingeland Ziekenhuis
  • Ziekenhuis Gelderse Vallei
  • Scheper ZiekenhuisRecruiting
  • Admiraal de Ruyter ZiekenhuisRecruiting
  • Beatrix Ziekenhuis
  • Groene Hart ZiekenhuisRecruiting
  • Martini ZiekenhuisRecruiting
  • University Medical Center GroningenRecruiting
  • Spaarne GasthuisRecruiting
  • Saxenburgh MCRecruiting
  • Ziekenhuis St Jansdal
  • Zuyderland Medisch CentrumRecruiting
  • Elkerliek ZiekenhuisRecruiting
  • BethesdaRecruiting
  • Medisch Centrum LeeuwardenRecruiting
  • Alrijne ZiekenhuisRecruiting
  • Maastricht UMC+
  • Isala DiaconessenhuisRecruiting
  • Radboud University Medical CenterRecruiting
  • Bravis ziekenhuisRecruiting
  • Erasmus Medisch CentrumRecruiting
  • Franciscus GasthuisRecruiting
  • Ikazia ZiekenhuisRecruiting
  • Franciscus VlietlandRecruiting
  • Antonius Ziekenhuis SneekRecruiting
  • RefajaRecruiting
  • Elisabeth-Tweesteden ZiekenhuisRecruiting
  • Diak. UtrechtRecruiting
  • Máxima Medisch CentrumRecruiting
  • Zaans Medisch CentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

The intervention group will receive low-dose digoxin

The placebo group will receive a matching placebo

Outcomes

Primary Outcome Measures

Composite of repeated HF hospitalizations, urgent HF Visits, and cardiovascular death

Secondary Outcome Measures

All-cause mortality
Cardiovascular death
(Repeated) HF hospitalization
Cost-effectiveness assessed by the Medical Consumption Questionnaire
Urgent HF hospital visits

Full Information

First Posted
December 13, 2018
Last Updated
May 9, 2023
Sponsor
University Medical Center Groningen
Collaborators
Disphar International B.V., Teva Nederland BV, Tiofarma BV, Netherlands Heart Foundation, Werkgroep Cardiologische centra Nederland
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1. Study Identification

Unique Protocol Identification Number
NCT03783429
Brief Title
Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Acronym
DECISION
Official Title
Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Disphar International B.V., Teva Nederland BV, Tiofarma BV, Netherlands Heart Foundation, Werkgroep Cardiologische centra Nederland

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Digoxin, Atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A national, multicenter, randomized, double-blind placebo controlled, clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind, placebo controlled
Allocation
Randomized
Enrollment
982 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
The intervention group will receive low-dose digoxin
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive a matching placebo
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Digoxin tablets will be given orally
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo tablets will be given orally
Primary Outcome Measure Information:
Title
Composite of repeated HF hospitalizations, urgent HF Visits, and cardiovascular death
Time Frame
Median of 3 years
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Median of 3 years
Title
Cardiovascular death
Time Frame
Median of 3 years
Title
(Repeated) HF hospitalization
Time Frame
Median of 3 years
Title
Cost-effectiveness assessed by the Medical Consumption Questionnaire
Time Frame
Median of 3 years
Title
Urgent HF hospital visits
Time Frame
Median of 3 years
Other Pre-specified Outcome Measures:
Title
All-cause hospitalizations
Time Frame
Median of 3 years
Title
Unscheduled cardiovascular hospital visits
Time Frame
Median of 3 years
Title
Days alive out of hospital
Time Frame
Median of 3 years
Title
Quality of Life assessed by the EUROQOL-5D-5L questionnaire
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.
Time Frame
Median of 3 years
Title
Heart rate in both AF and sinus rhythm
Time Frame
Median of 3 years
Title
To assess side effects (SUSARs) associated with study medication
Time Frame
Median of 3 years
Title
Initiation of (recurrence of) AF in patients with sinus rhythm at baseline
Time Frame
Median of 3 years
Title
Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline
Time Frame
Median of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michiel Rienstra, MD, PhD
Phone
+31-50-361-1327
Email
m.rienstra@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Rienstra, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter van der Meer, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk J van Veldhuisen, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Zorggroep Twente
City
Almelo
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Meander Medisch Centrum
City
Amersfoort
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
BovenIJ Ziekenhuis
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Rode Kruis Ziekenhuis
City
Beverwijk
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Tergooi
City
Blaricum
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ijsselland Ziekenhuis
City
Capelle Aan Den IJssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Haaglanden Medisch Centrum
City
Den Haag
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Van Weel Bethesda
City
Dirksland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Slingeland Ziekenhuis
City
Doetinchem
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Scheper Ziekenhuis
City
Emmen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Admiraal de Ruyter Ziekenhuis
City
Goes
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Beatrix Ziekenhuis
City
Gorinchem
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Spaarne Gasthuis
City
Haarlem
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Saxenburgh MC
City
Hardenberg
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ziekenhuis St Jansdal
City
Harderwijk
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Elkerliek Ziekenhuis
City
Helmond
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Bethesda
City
Hoogeveen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Alrijne Ziekenhuis
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht UMC+
City
Maastricht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Isala Diaconessenhuis
City
Meppel
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Bravis ziekenhuis
City
Roosendaal
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Franciscus Gasthuis
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Franciscus Vlietland
City
Schiedam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Antonius Ziekenhuis Sneek
City
Sneek
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Refaja
City
Stadskanaal
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Elisabeth-Tweesteden Ziekenhuis
City
Tilburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Diak. Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Máxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Zaans Medisch Centrum
City
Zaandam
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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