Digoxin After Acute Heart Failure

NCT07321509 | Recruiting Phase 4 DMC

• 1 other identifier: 16824
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Systolic Heart Failure; Digoxin; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who are "well and alive" (alive and with quality-of-life score ≥75)

  "Well and alive" is defined as the participant being alive and having a quality-of-life score ≥75 on a 0-100 scale at the specified follow-up time point. The primary outcome is the proportion of participants who meet both criteria (alive and QoL ≥75) at 180 days after index hospital discharge.

  180 days

Study Arms (2)

Digoxin arm

EXPERIMENTAL

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.

Other: Usual Care; Drug: Digoxin

Usual care alone

EXPERIMENTAL

Participants assigned to this arm will receive usual care alone, without digoxin or any additional study medication.

Other: Usual Care

Interventions

Usual Care OTHER

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

Digoxin arm; Usual care alone

Digoxin DRUG

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.

Digoxin arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Resting heart rate \< 60 bpm in sinus rhythm or \< 70 bpm in atrial fibrillation.
• 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.
• Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m² (based on a sample obtained within the previous month).
• Presence of a mechanical ventricular assist device.
• Planned implantation of a ventricular assist device or cardiac transplantation.
• Non-cardiac comorbidities with a limited life expectancy (less than or equal to the study duration).
• Non-cardiac conditions (neurological or orthopedic) preventing performance of the 6-minute walk test (6MWT).
• Body mass index (BMI) ≥ 35 kg/m².
• Amyloid, hypertrophic obstructive, or constrictive cardiomyopathy.
• Presence of an accessory atrioventricular conduction pathway (e.g., Wolff-Parkinson-White syndrome).
• History of symptomatic or sustained ventricular tachyarrhythmia (≥ 30 seconds).
• Intermittent complete atrioventricular block or Mobitz type II second-degree AV block without pacemaker or ICD.
• Severe aortic valvular disease (grade III/III) with indication for invasive treatment.
• Complex congenital heart disease.
• Known hypersensitivity to digoxin (including prior adverse reactions).

Sponsors & Collaborators

• Guillermo Liniado: lead
• Hospital General de Agudos "Dr. Cosme Argerich": collaborator

Study Sites (1)

Hospital General de Agudos Dr Cosme Argerich

Buenos Aires, Buenos Aires F.D., 1414, Argentina

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

Digoxin

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Guillermo Ernesto Liniado, MD

  STUDY CHAIR

Central Study Contacts

Guillermo Ernesto Liniado, MD

CONTACT

+5491168615900; guillermoliniado@yahoo.com.ar

Juan Alberto Gagliardi, MD

CONTACT

+5491154013300; juanalbertogagliardi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Model Details: Two-arm parallel assignment with 1:1 randomization to low-dose digoxin plus usual care versus usual care alone

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 7, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 16, 2027
• Study Completion (Estimated): December 16, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

AR (1)