Assessment of the Efficacy and Safety of a Short Term Treatment With Digoxin on Patients With Acute Heart Failure Syndromes. A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- 30 days mortality and rehospitalization rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Confirmed or suspected diagnosis of ACS within 45 days before inclusion.
- •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.
- •Previous treatment with digoxin within 15 days before inclusion or contra-indications to digoxin.
- •Inability to follow instructions or comply with follow-up procedures.
研究组 & 干预措施
Digoxin
Oral digoxin 0.25 mg: one pill per day for 30 consecutive days.
干预措施: Digoxin (Drug)
Placebo
Oral placebo for 30 days.
干预措施: Placebo (Drug)
结局指标
主要结局
30 days mortality and rehospitalization rate
时间窗: 30 days
次要结局
- Hemodynamic improvement(3 days)
- Need for hospitalization(3 days)
- Improvement of patient-reported dyspnea([Time Frame: 6, 12, and 24 hours from start of the study medication])
- Length of stay in hospital(from baseline to hospital discharge)
- AUC of dyspnea VAS scores(3 days)
- Dyspnea resolution time(3 days)
- Digoxin related adverse events(30 days)
- Worsening renal function(30 days)
研究者
Pr. Semir Nouira
Professor
University of Monastir