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COMPLETED
NCT03783429
PHASE4

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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%).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

982

Start Date

2020-07-01

Completion Date

2025-11-13

Last Updated

2026-04-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Digoxin

Digoxin tablets will be given orally

DRUG

Placebos

Placebo tablets will be given orally

Locations (44)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Zorggroep Twente

Almelo, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

BovenIJ Ziekenhuis

Amsterdam, Netherlands

Gelre Ziekenhuizen

Apeldoorn, Netherlands

Rijnstate Ziekenhuis

Arnhem, Netherlands

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

Tergooi

Blaricum, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Ijsselland Ziekenhuis

Capelle aan den IJssel, Netherlands

Reinier de Graaf Gasthuis

Delft, Netherlands

Deventer Ziekenhuis

Deventer, Netherlands

Van Weel Bethesda

Dirksland, Netherlands

Slingeland Ziekenhuis

Doetinchem, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Scheper Ziekenhuis

Emmen, Netherlands

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

Beatrix Ziekenhuis

Gorinchem, Netherlands

Groene Hart Ziekenhuis

Gouda, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Spaarne Gasthuis

Haarlem, Netherlands

Saxenburgh MC

Hardenberg, Netherlands

Ziekenhuis St Jansdal

Harderwijk, Netherlands

Zuyderland Medisch Centrum

Heerlen, Netherlands

Elkerliek Ziekenhuis

Helmond, Netherlands

Bethesda

Hoogeveen, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Alrijne Ziekenhuis

Leiden, Netherlands

Maastricht UMC+

Maastricht, Netherlands

Isala Diaconessenhuis

Meppel, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Bravis ziekenhuis

Roosendaal, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Franciscus Gasthuis

Rotterdam, Netherlands

Ikazia Ziekenhuis

Rotterdam, Netherlands

Franciscus Vlietland

Schiedam, Netherlands

Antonius Ziekenhuis Sneek

Sneek, Netherlands

Refaja

Stadskanaal, Netherlands

Haaglanden Medisch Centrum

The Hague, Netherlands

Elisabeth-Tweesteden Ziekenhuis

Tilburg, Netherlands

Diak. Utrecht

Utrecht, Netherlands

Máxima Medisch Centrum

Veldhoven, Netherlands

Zaans Medisch Centrum

Zaandam, Netherlands