Effects of Digoxin in Modern Heart Failure Treatment
Key facts
- Where
- Lisbon, PortugáliaSee the site
- Phase
- 4. fázis
Where in Portugália
- Unidade Local De Saude De Sao Jose E.P.E.Lisbon, PortugáliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Unidade Local De Saude De Sao Jose E.P.E.
- Trial code
- EU 2024-513448-26-00
- Record updated
- 2026. április 7.
- Original description
To assess the effectiveness of Digoxin in functional capacity and cardiac function when combined with standard of care modern heart failure treatment.Read full original descriptionShow less
To assess the effectiveness of Digoxin in functional capacity and cardiac function when combined with standard of care modern heart failure treatment.
Inclusion: Chronic heart failure with reduced ejection fraction (LVEF ≤45%) with at least 6 months of maximally tolerated class I medications (ARNi or ACEiplus beta-blockers plus SGLT2 inhibitors plus MRA) unless contraindicated; Symptomatic heart failure with at least New York Heart Association (NYHA) class ≥ II in which Digoxin may be considered according tocurrent European Guidelines; Age ≥ 18 years old; Ability to provide informed consent and willingness to comply with studyprocedures.
Exclusion: Already using Digoxin or having used it on the last 9 days (washout period); New heart failure medication in the previous 6 months; Change in class I HF dose (ARNi, ACEi, ARB, beta-blockers, SGLT2 inhibitors or MRA) in the previous 3 months; Arrhythmias caused by cardiac glycoside intoxication; Sick sinus syndrome without pacemaker or Implantable cardioverter-defibrillators (ICD); Wolff-Parkinson-White syndrome; Heart rate below 55 bpm at rest in sinus rhythm or below 70 bpm in AF in patients without CRT or cardiac physiologic pacing; Hypersensitivity to Digoxin, other digitalis glycosides or to any of the excipients; Recent (<6 months): myocardial infarction, coronary revascularization, surgery or catheter intervention for valvular heart disease, stroke, or cerebral ischaemia, start of heart failure device therapy potentially improving left ventricular ejection fraction or HF symptoms (e.g. cardiac resynchronization therapy, cardiac contractility modulation, baroreflex activation therapy); Significant renal insufficiency (Glomerular filtration rate (GFR) ≤ 15mL/min) as evaluated by the Cockcroft-Gault formula; Persistent potassium below 3.2 mmol/L; Age < 18 years old; Pregnant or lactating women. Woman of childbearing potential who do not accept to use the methods of contraception suggested for the trial; NTproBNP values < 125pg/mL; Ventricular tachycardia or ventricular fibrillation; Persistent hypercalcaemia or hypomagnesaemia; Grade II-III AV block without a pacemaker or ICD.