NCT07321509

Digoxin After Acute Heart Failure

Digoxina After Acute Hearte Failure

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Guillermo Liniado · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Acute Heart Failure (AHF)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-16
• Primary completion: 2027-12-16
• Completion: 2028-12-16
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Argentina