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

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Updated on 16 March 2022

See if I qualify

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 Identifier	NCT03783429
Sponsor	University Medical Center Groningen
Last Modified on	16 March 2022

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