Digoxin After Acute Heart Failure (DIG-DICA)

Q: Who can participate in NCT07321509?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07321509?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Evaluation of Digoxin Therapy in Patients With Heart Failure After Acute Decompensation

Digoxin After Acute Heart Failure (DIG-DICA) (NCT07321509) is a Phase 4 interventional studying Acute Heart Failure (AHF), sponsored by Hospital General de Agudos "Dr. Cosme Argerich". RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Acute Heart Failure (AHF) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female ≥ 18 years of age who have signed written willing to sign a consent form and are willing and able to complete treatment and follow-up. 2. Recent hospitalization or emergency department visit for decompensated heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 40%). 3. Resting heart rate ≥ 60 bpm in patients without a pacemaker. 4. Distance walked on the 6-minute walk test (6MWT) ≤ 450 meters and/or less than 80% of the predicted value. 5. NT-proBNP ≥ 450 pg/mL, or ≥ 900 pg/mL in patients with atrial fibrillation, and/or echocardiographic criteria of congestion \- Who Should NOT Join This Trial: 1. Resting heart rate \< 60 bpm in sinus rhythm or \< 70 bpm in atrial fibrillation. 2. 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. 3. Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m² (based on a sample obtained within the previous month). 4. Presence of a mechanical ventricular assist device. 5. Planned implantation of a ventricular assist device or cardiac transplantation. 6. Non-cardiac comorbidities with a limited life expectancy (less than or equal to the study duration). 7. Non-cardiac conditions (neurological or orthopedic) preventing performance of the 6-minute walk test (6MWT). 8. Body mass index (BMI) ≥ 35 kg/m². 9. Amyloid, hypertrophic obstructive, or constrictive cardiomyopathy. 10. Presence of an accessory atrioventricular conduction pathway (e.g., Wolff-Parkinson-White syndrome). 11. History of symptomatic or sustained ventricular tachyarrhythmia (≥ 30 seconds). 12. Intermittent complete atrioventricular block or Mobitz type II second-degree AV block without pacemaker or ICD. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Male or female ≥ 18 years of age who have signed written informed consent and are willing and able to complete treatment and follow-up. 2. Recent hospitalization or emergency department visit for decompensated heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 40%). 3. Resting heart rate ≥ 60 bpm in patients without a pacemaker. 4. Distance walked on the 6-minute walk test (6MWT) ≤ 450 meters and/or less than 80% of the predicted value. 5. NT-proBNP ≥ 450 pg/mL, or ≥ 900 pg/mL in patients with atrial fibrillation, and/or echocardiographic criteria of congestion \- Exclusion Criteria: 1. Resting heart rate \< 60 bpm in sinus rhythm or \< 70 bpm in atrial fibrillation. 2. 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. 3. Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m² (based on a sample obtained within the previous month). 4. Presence of a mechanical ventricular assist device. 5. Planned implantation of a ventricular assist device or cardiac transplantation. 6. Non-cardiac comorbidities with a limited life expectancy (less than or equal to the study duration). 7. Non-cardiac conditions (neurological or orthopedic) preventing performance of the 6-minute walk test (6MWT). 8. Body mass index (BMI) ≥ 35 kg/m². 9. Amyloid, hypertrophic obstructive, or constrictive cardiomyopathy. 10. Presence of an accessory atrioventricular conduction pathway (e.g., Wolff-Parkinson-White syndrome). 11. History of symptomatic or sustained ventricular tachyarrhythmia (≥ 30 seconds). 12. Intermittent complete atrioventricular block or Mobitz type II second-degree AV block without pacemaker or ICD. 13. Severe aortic valvular disease (grade III/III) with indication for invasive treatment. 14. Complex congenital heart disease. 15. Known hypersensitivity to digoxin (including prior adverse reactions). 16. Current treatment with digoxin. 17. Participation in another clinical trial (excluding observational registries). 18. Pregnant or breastfeeding women, or women with the potential to become pregnant during the study period. \-

Treatments Being Tested

OTHER

Usual Care

Standard clinical care provided according to local practice guidelines. No digoxin or other study-specific medication will be administered.

DRUG

Digoxin

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hospital General de Agudos Dr Cosme Argerich

Buenos Aires, Buenos Aires F.D., Argentina

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07321509), the sponsor (Hospital General de Agudos "Dr. Cosme Argerich"), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07321509 clinical trial studying?

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 Card… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07321509?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07321509?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07321509. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07321509. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.