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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.
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 ? Additionnel treatments for AHF were given according left to ACCF/AHA for the managementof heart failure .
Blood testing for scanner digoxin magerments will be confirmed at H8, h24 and H72 after the post protocol treatment admession treatment administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin | Active Comparator | Oral digoxin 0.25 mg: one pill per day for 30 consecutive days. |
|
| Placebo | Placebo Comparator | Oral placebo for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Digoxin 0.25 mg pills |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 30 days mortality and rehospitalization rate | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic improvement | 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. | 3 days |
| Need for hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nouira Semir, Professor | Contact | 73106000 | 00216 | semir.nouira@rns.tn |
| Bzeouich Nasri, MD | Contact | 52919170 | 00216 | medecinasri@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nouira Semir, Professor | University Hospital of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahloul University Hospital | Recruiting | Hammam Sousse | Sousse Governorate | 4011 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16365214 | Background | 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. | |
| 9036306 |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Drug |
Placebo pills |
|
| 3 days |
| Length of stay in hospital | from baseline to hospital discharge |
| AUC of dyspnea VAS scores | Change in patient-reported dyspnea as quantified by the area under the curve (AUC) of visual analogue scale (VAS) scores (0-100 mm scale) : a dyspnea VAS score of 0 corresponds to the patient's subjective feeling of "I Can Breathe Normally" and a dyspnea VAS score of 100 corresponds to "I Can't Breathe At All. | 3 days |
| Improvement of patient-reported dyspnea | 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. | [Time Frame: 6, 12, and 24 hours from start of the study medication] |
| Dyspnea resolution time | defined as the time between the start of study drug and the reduction of at least 50% of the dyspnea VAS score from baseline. | 3 days |
| Digoxin related adverse events | 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). | 30 days |
| Worsening renal function | worsening renal function under treatment is defined as a relative increase in serum creatinine of at least 25% from baseline value. | 30 days |
| Fattouma Bourguiba University Hospital | Recruiting | Monastir | 5000 | Tunisia |
|
| Background |
| Digitalis 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. |
| 24067296 | Background | Hashim 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. |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |