Cardiomyopathy Clinical Trials

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Digoxina After Acute Hearte Failure

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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

• \-

Locations
Other Locations
Argentina
Hospital General de Agudos Dr Cosme Argerich
RECRUITING
Buenos Aires
Contact Information
Primary
Guillermo Ernesto Liniado, MD
guillermoliniado@yahoo.com.ar
+5491168615900
Backup
Juan Alberto Gagliardi, MD
juanalbertogagliardi@gmail.com
+5491154013300
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2028-12-16
Participants
Target number of participants: 120
Treatments
Experimental: Digoxin arm
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.
Experimental: Usual care alone
Participants assigned to this arm will receive usual care alone, without digoxin or any additional study medication.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital General de Agudos Dr. Cosme Argerich
Leads: Guillermo Liniado

This content was sourced from clinicaltrials.gov