Digoxin Short Term Treatment Assessment Randomized Trial in AHF (DIG-STA-AHF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02544815|
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : February 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Heart Failure||Drug: Digoxin Drug: Placebo||Phase 3|
AHFS management is challenging given the heterogeniety of the patient population, absence of a universally accepted definition, incomplete understanding of its pathophysiology, and lack of evidence based guidelines.
The majority of patients appear to respond well to initial therapies consisting of loop diuretics and vasoactive agents. however, this treatments failed to decrease post-discharge mortality and readmission rates which represent the most important goal in AHFS.
In the last few years, many drugs has been tested in AHFS setting trying to adress this issue, however results has been disappointing in term of efficacy and / or safety.
Although evidence supports the beneficial effects of digoxin on hemodynamic, neurohormonal, and electrophysiological parameters in patients with CHF, recent publications has rose concerns about its safety profile and therefore decreasing its use.
The effects of digoxin alone or in combination with other vasodilators are seen within few hours of its administration and result in increased cardiac output, decreased pulmonary wedge pressure, increased ejection fraction, and improved neurohormonal profile without changes in blood pressure.
All this findings made us rose the question of whether digoxin is effective or not in short term treatment of acute heart failure ?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Assessment of the Efficacy and Safety of a Short Term Treatment With Digoxin on Patients With Acute Heart Failure Syndromes. A Randomized Controlled Trial.|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||January 31, 2040|
|Estimated Study Completion Date :||January 31, 2040|
Active Comparator: Digoxin
Oral digoxin 0.25 mg: one pill per day for three consecutive days.
Digoxin 0.25 mg pills
Placebo Comparator: Placebo
Oral placebo for three days.
- AUC of dyspnea VAS scores [ Time Frame: from baseline to day 3 ]Change in patient-reported dyspnea as quantified by the area under the curve (AUC) of visual analogue scale (VAS) scores (0-100 mm scale) from baseline to day 3.
- Improvement of patient-reported dyspnea [ Time Frame: 6, 12, and 24 hours from start of the study medication ]Improvement of patient-reported dyspnea relative to the start of study drug using a 5 point likert scale at 6, 12, and 24 hours, where a responder was a patient with better or markedly betted dyspnea at all three of those time points.
- Dyspnea resolution time [ Time Frame: from baseline to day 3 ]Dyspnea resolution time is defined as the time between the start of study drug and the reduction of at least 50% of the dyspnea VAS score from baseline.
- Hemodynamic improvement [ Time Frame: from baseline to day 3 ]Change in hemodynamic parameters as quantified by the area under the curve of bio-impedance thoracic fluid contenant (TFC), lung ultrasound (LUS) congestion score and BNP serum levels, from baseline to day 3.
- Need for hospitalization [ Time Frame: day 3 ]The need for hospitalization after 3 days of ED care.
- In-hospital length of stay [ Time Frame: from baseline to hospital discharge ]In-hospital length of stay measured from randomization to hospital discharge.
- Death or readmission rates [ Time Frame: within 30 days from hospital discharge ]A composite outcome of Death or readmission within the first 30 days of hospital discharge.
- Digoxin related adverse events [ Time Frame: from administration of study drug to 30 days after ]
Occurrence of major adverse events related to digoxin and implicating its discontinuation.
Admitted major side effects of digoxin are: Severe ventricular arrhythmias including ventricular tachycardia or fibrillation, Severe bradycardia, Second- or third-degree heart block not responsive to atropine, Serum potassium levels exceeding 5.5 mEq/L with rapidly progressive signs and symptoms of digoxin toxicity, Neurologic symptoms (eg, visual disturbances, disorientation, and confusion).
- Worsening renal function [ Time Frame: from administration of study drug to 30 days after ]
Worsening of renal function rates within day 30 from starting of the study treatment.
Worsening renal function under treatment is defined as a relative increase in serum creatinine of at least 25% from baseline value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544815
|Contact: Nouira Semir, Professor||73106000 ext firstname.lastname@example.org|
|Contact: Bzeouich Nasri, MD||52919170 ext email@example.com|
|Sahloul University Hospital||Recruiting|
|Hammam sousse, Sousse, Tunisia, 4011|
|Contact: Boukef Riadh, Professor 73460678 ext 00216 firstname.lastname@example.org|
|Fattouma Bourguiba University Hospital||Recruiting|
|Monastir, Tunisia, 5000|
|Contact: Nouira Semir, Professor 73641144 ext 00216 email@example.com|
|Contact: nasri Bzeouich, MD 52919170 ext 00216 firstname.lastname@example.org|
|Principal Investigator: Nouira Semir, Professor|
|Sub-Investigator: Beltaief Kaouthar, MD|
|Sub-Investigator: Bzeouich Nasri, MD|
|Principal Investigator:||Nouira Semir, Professor||University Hospital of Monastir|