Acute Heart Failure (AHF)Phase 4DIG-DICANCT07321509
Digoxin After Acute Heart Failure (DIG-DICA)
A Phase 4 study testing Digoxin in people with Acute Heart Failure (AHF), run by Hospital General de Agudos "Dr. Cosme Argerich" at 1 site in Argentina.
Trial summary
The DIG-DICA trial is a randomized, controlled, open-label, single-center study designed to evaluate whether adding low-dose digoxin to optimal medical therapy after an episode of acute decompensated heart failure improves patients' clinical status and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteArgentina
- Study dates
- 16 Dec 2025to 16 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age who have signed written informed consent and are willing and able to complete treatment and follow-up.
- Recent hospitalization or emergency department visit for decompensated heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 40%).
- Resting heart rate ≥ 60 bpm in patients without a pacemaker.
- Distance walked on the 6-minute walk test (6MWT) ≤ 450 meters and/or less than 80% of the predicted value.
- NT-proBNP ≥ 450 pg/mL, or ≥ 900 pg/mL in patients with atrial fibrillation, and/or echocardiographic criteria of congestion
- -
Who cannot join
- Resting heart rate < 60 bpm in sinus rhythm or < 70 bpm in atrial fibrillation.
- Myocardial infarction, acute coronary syndrome, myocarditis, percutaneous coronary intervention, or recent implantation (within the past 3 months) of cardiac resynchronization therapy (CRT), pacemaker, or implantable cardioverter-defibrillator (ICD); cardiac surgery or stroke within the past 30 days.
- Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m² (based on a sample obtained within the previous month).
- Presence of a mechanical ventricular assist device.
- Planned implantation of a ventricular assist device or cardiac transplantation.
- Non-cardiac comorbidities with a limited life expectancy (less than or equal to the study duration).
Show all 19Show fewer
- Non-cardiac conditions (neurological or orthopedic) preventing performance of the 6-minute walk test (6MWT).
- Body mass index (BMI) ≥ 35 kg/m².
- Amyloid, hypertrophic obstructive, or constrictive cardiomyopathy.
- Presence of an accessory atrioventricular conduction pathway (e.g., Wolff-Parkinson-White syndrome).
- History of symptomatic or sustained ventricular tachyarrhythmia (≥ 30 seconds).
- Intermittent complete atrioventricular block or Mobitz type II second-degree AV block without pacemaker or ICD.
- Severe aortic valvular disease (grade III/III) with indication for invasive treatment.
- Complex congenital heart disease.
- Known hypersensitivity to digoxin (including prior adverse reactions).
- Current treatment with digoxin.
- Participation in another clinical trial (excluding observational registries).
- Pregnant or breastfeeding women, or women with the potential to become pregnant during the study period.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital General de Agudos Dr Cosme Argerich
Buenos Aires, Buenos Aires F.D., 1414
Guillermo Liniado, MD, +5491168615900, guillermoliniado@yahoo.com.ar
About this study
Official title: Evaluation of Digoxin Therapy in Patients With Heart Failure After Acute Decompensation
The DIG-DICA trial is a randomized, controlled, open-label, single-center study designed to evaluate whether adding low-dose digoxin to optimal medical therapy after an episode of acute decompensated heart failure improves patients' clinical status and quality of life. The study enrolls adults with heart failure with reduced ejection fraction (HFrEF) who have recently stabilized after hospitalization or urgent care for decompensation. The primary aim is to determine whether digoxin increases the proportion of patients who are "Alive and Well" at 180 days-defined by achieving a Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score ≥75. The trial also explores effects on symptoms, functional capacity, biomarkers, renal function, and major cardiovascular events. The goal is to clarify whether modern low-dose digoxin provides meaningful clinical benefit in contemporary heart failure management.
Read the detailed description
The DIG-DICA study is a randomized, controlled, open-label, single-center trial designed to evaluate the clinical impact of low-dose digoxin in patients with heart failure with reduced ejection fraction (HFrEF) following an episode of acute decompensation. Despite significant advances in guideline-directed medical therapy (GDMT), many patients continue to experience persistent symptoms, recurrent congestion, impaired functional capacity, and reduced quality of life after stabilization. Digoxin, at low serum concentrations, remains a potentially valuable adjunct therapy, but contemporary evidence in the post-decompensation setting is limited.
Eligible patients are adults with HFrEF hospitalized or treated in urgent care for acute heart failure decompensation who have achieved clinical stabilization and are receiving standardized GDMT according to current guidelines. Participants are randomized to either continue their usual care alone or receive low-dose digoxin in addition to standard therapy. The dosing strategy aims to achieve low therapeutic concentrations consistent with current safety recommendations.
The primary outcome is the proportion of patients who are "Alive and Well" at 180 days, defined as achieving a Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score ≥75. Secondary assessments include changes in symptoms, functional capacity (6-minute walk test and timed walk), N-terminal pro-B-type natriuretic peptide (NT-proBNP), renal function, and other markers of clinical course. Exploratory analyses evaluate the incidence of major cardiovascular events, including cardiovascular death, hospitalizations for heart failure, and urgent visits for decompensation.
This study seeks to provide contemporary evidence on whether the addition of low-dose digoxin after an acute heart failure episode can meaningfully improve medium-term clinical status, patient-reported outcomes, and stability in routine practice. The results are intended to clarify the role of digoxin as a practical, accessible, and low-cost adjunct in the modern management of HFrEF.
- Conditions
- Acute Heart Failure (AHF)
- Being tested
- Usual Care, Digoxin
- Keywords
- Systolic Heart Failure, Digoxin, Quality of Life
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Standard clinical care provided according to local practice guidelines. No digoxin or other study-specific medication will be administered.
DigoxinDrug
Oral digoxin administered in addition to usual care. Dose selection and adjustments will be based on creatinine clearance using a validated online digoxin dosing calculator according to predefined protocol tables.
| Study group | Role | What they receive |
|---|---|---|
| Digoxin arm | Experimental | Participants will receive usual care plus oral digoxin. The initial dose and subsequent dose adjustments will be determined according to creatinine clearance using a web-based digoxin dosing calculator, following a predefined dosing table in the protocol. Receives: Other: Usual Care; Drug: Digoxin |
| Usual care alone | Experimental | Participants assigned to this arm will receive usual care alone, without digoxin or any additional study medication. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who are "well and alive" (alive and with quality-of-life score ≥75)
"Well and alive" is defined as the participant being alive and having a quality-of-life score ≥75 on a 0-100 scale at the specified follow-up time point.
The primary outcome is the proportion of participants who meet both criteria (alive and QoL ≥75) at 180 days after index hospital discharge.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start16 Dec 2025
- Primary completion16 Dec 2027 (estimated)
- Study completion16 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel assignment with 1:1 randomization to low-dose digoxin plus usual care versus usual care alone
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Agudos "Dr. Cosme Argerich"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Liniado, Hospital General de Agudos "Dr. Cosme Argerich"
- Investigators
- Guillermo Ernesto Liniado, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321509
- Sponsor's protocol ID
- 16824
- Acronym
- DIG-DICA
- Status last verified
- May 2026
- First submitted
- 9 Dec 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Digoxin Therapy in Patients With Heart Failure After Acute Decompensation
- ClinicalTrials.gov ID
- NCT07321509
- Acronym / sponsor ID
- DIG-DICA / 16824
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Systolic Heart Failure, Digoxin, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital General de Agudos "Dr. Cosme Argerich"University, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 16 Dec 2027 (estimated)
- Study completion
- 16 Dec 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DIG-DICA trial is a randomized, controlled, open-label, single-center study designed to evaluate whether adding low-dose digoxin to optimal medical therapy after an episode of acute decompensated heart failure improves patients' clinical status and quality of life. The study enrolls adults with heart failure with reduced ejection fraction (HFrEF) who have recently stabilized after hospitalization or urgent care for decompensation. The primary aim is to determine whether digoxin increases the proportion of patients who are "Alive and Well" at 180 days-defined by achieving a Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score ≥75. The trial also explores effects on symptoms, functional capacity, biomarkers, renal function, and major cardiovascular events. The goal is to clarify whether modern low-dose digoxin provides meaningful clinical benefit in contemporary heart failure management.
Detailed description
The DIG-DICA study is a randomized, controlled, open-label, single-center trial designed to evaluate the clinical impact of low-dose digoxin in patients with heart failure with reduced ejection fraction (HFrEF) following an episode of acute decompensation. Despite significant advances in guideline-directed medical therapy (GDMT), many patients continue to experience persistent symptoms, recurrent congestion, impaired functional capacity, and reduced quality of life after stabilization. Digoxin, at low serum concentrations, remains a potentially valuable adjunct therapy, but contemporary evidence in the post-decompensation setting is limited.
Eligible patients are adults with HFrEF hospitalized or treated in urgent care for acute heart failure decompensation who have achieved clinical stabilization and are receiving standardized GDMT according to current guidelines. Participants are randomized to either continue their usual care alone or receive low-dose digoxin in addition to standard therapy. The dosing strategy aims to achieve low therapeutic concentrations consistent with current safety recommendations.
The primary outcome is the proportion of patients who are "Alive and Well" at 180 days, defined as achieving a Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score ≥75. Secondary assessments include changes in symptoms, functional capacity (6-minute walk test and timed walk), N-terminal pro-B-type natriuretic peptide (NT-proBNP), renal function, and other markers of clinical course. Exploratory analyses evaluate the incidence of major cardiovascular events, including cardiovascular death, hospitalizations for heart failure, and urgent visits for decompensation.
This study seeks to provide contemporary evidence on whether the addition of low-dose digoxin after an acute heart failure episode can meaningfully improve medium-term clinical status, patient-reported outcomes, and stability in routine practice. The results are intended to clarify the role of digoxin as a practical, accessible, and low-cost adjunct in the modern management of HFrEF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment with 1:1 randomization to low-dose digoxin plus usual care versus usual care alone
| Arm | Type | Receives |
|---|---|---|
| Digoxin arm | Experimental | Other: Usual Care, Drug: DigoxinParticipants will receive usual care plus oral digoxin. The initial dose and subsequent dose adjustments will be determined according to creatinine clearance using a web-based digoxin dosing calculator, following a predefined dosing table in the protocol. |
| Usual care alone | Experimental | Other: Usual CareParticipants assigned to this arm will receive usual care alone, without digoxin or any additional study medication. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years of age who have signed written informed consent and are willing and able to complete treatment and follow-up.
- Recent hospitalization or emergency department visit for decompensated heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 40%).
- Resting heart rate ≥ 60 bpm in patients without a pacemaker.
- Distance walked on the 6-minute walk test (6MWT) ≤ 450 meters and/or less than 80% of the predicted value.
- NT-proBNP ≥ 450 pg/mL, or ≥ 900 pg/mL in patients with atrial fibrillation, and/or echocardiographic criteria of congestion
Key exclusion criteria (19 listed)
- Resting heart rate < 60 bpm in sinus rhythm or < 70 bpm in atrial fibrillation.
- Myocardial infarction, acute coronary syndrome, myocarditis, percutaneous coronary intervention, or recent implantation (within the past 3 months) of cardiac resynchronization therapy (CRT), pacemaker, or implantable cardioverter-defibrillator (ICD); cardiac surgery or stroke within the past 30 days.
- Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m² (based on a sample obtained within the previous month).
- Presence of a mechanical ventricular assist device.
- Planned implantation of a ventricular assist device or cardiac transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareStandard clinical care provided according to local practice guidelines. No digoxin or other study-specific medication will be administered. | Other | Digoxin arm, Usual care alone |
| DigoxinOral digoxin administered in addition to usual care. Dose selection and adjustments will be based on creatinine clearance using a validated online digoxin dosing calculator according to predefined protocol tables. | Drug | Digoxin arm |
Primary outcome
Proportion of participants who are "well and alive" (alive and with quality-of-life score ≥75)
Time frame: 180 days
"Well and alive" is defined as the participant being alive and having a quality-of-life score ≥75 on a 0-100 scale at the specified follow-up time point. The primary outcome is the proportion of participants who meet both criteria (alive and QoL ≥75) at 180 days after index hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Ernesto Liniado, MD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Digoxin in people with Acute Heart Failure (AHF), run by Hospital General de Agudos "Dr. Cosme Argerich" at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Ernesto Liniado, MD (+5491168615900, guillermoliniado@yahoo.com.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who are "well and alive" (alive and with quality-of-life score ≥75) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.