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Effects of Digoxin in Modern Heart Failure Treatment
EU CTIS ID: 2024-513448-26-00
What this study is testing
To assess the effectiveness of Digoxin in functional capacity and cardiac function when combined with standard of care modern heart failure treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Already using Digoxin or having used it on the last 9 days (washout period).
- Pregnant or lactating women. Woman of childbearing potential who do not accept to use the methods of contraception suggested for the trial.
- 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.
- 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.
See the full eligibility criteria
- 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.
- Already using Digoxin or having used it on the last 9 days (washout period).
- Pregnant or lactating women. Woman of childbearing potential who do not accept to use the methods of contraception suggested for the trial.
- 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.
- 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.
- NTproBNP values < 125pg/mL.
- Ventricular tachycardia or ventricular fibrillation
- Arrhythmias caused by cardiac glycoside intoxication
- Persistent potassium below 3.2 mmol/L.
- Persistent hypercalcaemia or hypomagnesaemia.
- Sick sinus syndrome without pacemaker or Implantable cardioverter-defibrillators (ICD).
- Grade II-III AV block without a pacemaker or 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.
- Age < 18 years old.
- Hypersensitivity to Digoxin, other digitalis glycosides or to any of the excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.