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Digoxin After Acute Heart Failure

NCT07321509 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Acute Heart Failure (AHF)

Interventions

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.

Sponsors & Collaborators

  • Hospital General de Agudos "Dr. Cosme Argerich"

    collaborator OTHER

  • Guillermo Liniado

    lead OTHER

Principal Investigators

  • Guillermo Ernesto Liniado, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2027-12-16
Completion
2028-12-16

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321509 on ClinicalTrials.gov