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

  • STATUS
    Recruiting
  • End date
    Jul 16, 2025
  • participants needed
    982
  • sponsor
    University Medical Center Groningen
Updated on 16 March 2022
heart failure
chronic heart failure
nt-probnp
b-type natriuretic peptide
digoxin

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%).

Details
Condition Heart Failure
Treatment placebos, Digoxin
Clinical Study IdentifierNCT03783429
SponsorUniversity Medical Center Groningen
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

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)
Other non-cardiac conditions with limited life expectancy (≤ duration of the study)
Scheduled for mechanical assist device or heart transplant
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
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