Digoxin Short Term Treatment Assessment Randomized Trial in AHF
DIG-STA-AHF
Assessment of the Efficacy and Safety of a Short Term Treatment With Digoxin on Patients With Acute Heart Failure Syndromes. A Randomized Controlled Trial.
1 other identifier
interventional
500
1 country
2
Brief Summary
AHFS management is challenging and most of the used drugs has failed to decrease post-discharge mortality and readmission rates which represent the most important goal in AHFS. Digoxin processes many characteristics of a beneficial drug for heart failure, however recent publications has rose concerns about its safety profile and therefore decreasing its use. Whether digoxin is efficient and safe in short term treatment of acute heart failure is a question that should be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedDecember 18, 2023
December 1, 2023
2.3 years
September 5, 2015
December 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
30 days mortality and rehospitalization rate
30 days
Secondary Outcomes (8)
Hemodynamic improvement
3 days
Need for hospitalization
3 days
Length of stay in hospital
from baseline to hospital discharge
AUC of dyspnea VAS scores
3 days
Improvement of patient-reported dyspnea
[Time Frame: 6, 12, and 24 hours from start of the study medication]
- +3 more secondary outcomes
Study Arms (2)
Digoxin
ACTIVE COMPARATOROral digoxin 0.25 mg: one pill per day for 30 consecutive days.
Placebo
PLACEBO COMPARATOROral placebo for 30 days.
Interventions
Eligibility Criteria
You may qualify if:
- Able to provide informed written consent.
- Male or female aged ≥18 years old.
- Admitted for acute heart failure defined by the presence of dypnea at rest or with minimal exertion , pulmonary congestion on chest radiograph ; and increased natriutic peptide concentrations ( BNP \>=350 pg/ml) or NTproBNP \>=1400 pg/ml ) .
- Able to be randomized within 12 hours from presentation to the hospital.
You may not qualify if:
- Pregnant or breast feeding women.
- Known severe or terminal renal failure.
- Previous hepatic impairment.
- Major surgery within 30 days.
- Hematocrit \< 25%.
- Alteration of consciousness GCS \< 15
- Critically ill patients needing immediate mechanical hemodynamic of ventilatory support.
- Severe arrhythmias including significant sinoatrial or atrioventricular blocks or WPW syndrome.
- Implantable cardiac devices including pacemakers and defibrillators.
- Hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
- Noncardiac pulmonary edema, including suspected sepsis.
- Severe pulmonary disease
- Significant stenotic valvular disease .
- Hyperkalemia \> 5.5 mmol /L .
- Administration of an investigational drug or implantation of an investigational device or participation in another trial within 30 days before screening.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sahloul University Hospital
Hammam Sousse, Sousse Governorate, 4011, Tunisia
Fattouma Bourguiba University Hospital
Monastir, 5000, Tunisia
Related Publications (3)
Gheorghiade M, Zannad F, Sopko G, Klein L, Pina IL, Konstam MA, Massie BM, Roland E, Targum S, Collins SP, Filippatos G, Tavazzi L; International Working Group on Acute Heart Failure Syndromes. Acute heart failure syndromes: current state and framework for future research. Circulation. 2005 Dec 20;112(25):3958-68. doi: 10.1161/CIRCULATIONAHA.105.590091. No abstract available.
PMID: 16365214BACKGROUNDDigitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997 Feb 20;336(8):525-33. doi: 10.1056/NEJM199702203360801.
PMID: 9036306BACKGROUNDHashim T, Elbaz S, Patel K, Morgan CJ, Fonarow GC, Fleg JL, McGwin G, Cutter GR, Allman RM, Prabhu SD, Zile MR, Bourge RC, Ahmed A. Digoxin and 30-day all-cause hospital admission in older patients with chronic diastolic heart failure. Am J Med. 2014 Feb;127(2):132-9. doi: 10.1016/j.amjmed.2013.08.006. Epub 2013 Sep 23.
PMID: 24067296BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nouira Semir, Professor
University Hospital of Monastir
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 5, 2015
First Posted
September 9, 2015
Study Start
May 1, 2023
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
December 18, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share