RecruitingPhase 4NCT07321509

Digoxin After Acute Heart Failure

Digoxina After Acute Hearte Failure


Sponsor

Guillermo Liniado

Enrollment

120 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether digoxin — an older heart medication — can help people who have recently been hospitalized for heart failure with a weak pumping heart (called heart failure with reduced ejection fraction, or HFrEF). Researchers want to see if it improves exercise capacity and reduces hospital readmissions. **You may be eligible if...** - You are 18 or older - You were recently in the hospital or emergency room for a heart failure flare-up - Your heart pumps at 40% or less of its normal capacity (LVEF ≤ 40%) - Your resting heart rate is 60 beats per minute or more (if you don't have a pacemaker) - You can walk 450 meters or less in a 6-minute walk test - You have elevated blood markers indicating your heart is under strain (NT-proBNP) **You may NOT be eligible if...** - You had a recent heart attack, heart surgery, or stroke (within the past 30 days) - Your kidneys are working very poorly - You have an implanted heart pump or are on a transplant waiting list - Your BMI is 35 or higher - You have a specific type of heart disease like hypertrophic or amyloid cardiomyopathy - You have a history of serious irregular heartbeats - You have an accessory heart pathway (like Wolff-Parkinson-White syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUsual Care

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

DRUGDigoxin

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)

Hospital General de Agudos Dr Cosme Argerich

Buenos Aires, Buenos Aires F.D., Argentina

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NCT07321509


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