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Effects of Digoxin in Modern Heart Failure Treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513448-26-00
Acronym
DIG-Mod HF
Enrollment
50
Registered
2024-09-13
Start date
2024-10-29
Completion date
Unknown
Last updated
2024-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

Peak oxygen consumption measured by Cardiopulmonary Exercise Test at 24 weeks., Global Work Index measured by Echocardiography at 24 weeks.

Detailed description

Composite of death, hospitalizations, and ventricular arrhythmia from baseline to 24 weeks., KCCQ-12 Score at 24 weeks., Changes in analytical parameters at 24 weeks: NTproBNP, Glomerular filtration rate, urine ratio of albumin/creatinine, C-reactive protein, aldosterone and renin plasma values., Cardiopulmonary exercise test parameters at 24 weeks: Peak oxygenconsumption (percentage of predicted), Oxygen consumption at anaerobic threshold, VE/VCO2 slope, Duration of exercise, Optimal point of ventilation., ECG parameters at 24 weeks: QRS interval., Echocardiography parameters at 24 weeks: Global Constructive Work, Global Wasted Work, Global Work Efficiency, Global Longitudinal Strain, Left Ventricular Ejection Fraction, Right ventricular fractional area change, Free-wall right ventricle longitudinal strain, Left ventricle end-diastolic volume, Left Atrial Reservoir Strain, Mechanical dispersion, E/e´

Interventions

DRUGNorit Carbomix 50 g granulado para suspensão oral
DRUGLanoxin MD 0
DRUG125 mg comprimido
DRUGDigiFab® (referred to as DIGIFAB) 40 mg/vial digoxin immune Fab

Sponsors

Unidade Local De Saude De Sao Jose E.P.E.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Peak oxygen consumption measured by Cardiopulmonary Exercise Test at 24 weeks., Global Work Index measured by Echocardiography at 24 weeks.

Secondary

MeasureTime frame
Composite of death, hospitalizations, and ventricular arrhythmia from baseline to 24 weeks., KCCQ-12 Score at 24 weeks., Changes in analytical parameters at 24 weeks: NTproBNP, Glomerular filtration rate, urine ratio of albumin/creatinine, C-reactive protein, aldosterone and renin plasma values., Cardiopulmonary exercise test parameters at 24 weeks: Peak oxygenconsumption (percentage of predicted), Oxygen consumption at anaerobic threshold, VE/VCO2 slope, Duration of exercise, Optimal point of ventilation., ECG parameters at 24 weeks: QRS interval., Echocardiography parameters at 24 weeks: Global Constructive Work, Global Wasted Work, Global Work Efficiency, Global Longitudinal Strain, Left Ventricular Ejection Fraction, Right ventricular fractional area change, Free-wall right ventricle longitudinal strain, Left ventricle end-diastolic volume, Left Atrial Reservoir Strain, Mechanical dispersion, E/e´

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026