Safety and Efficacy of the Combination of Furosemide 40 mg + Amiloride Hydrochloride 10 mg in the Reduction of Edema of Cardiac Origin in Patients With Congestive Heart Failure Functional Class II (NYHA)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
研究概览
简要总结
The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)
详细描述
General Purpose
- To comparatively evaluate the tolerability and efficacy of a fixed combination of furosemide (40 mg) and amiloride (10 mg) compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA)
Specific Purposes
- To evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
- To evaluate the efficacy of the fixed combination of furosemide and amiloride in reducing edema of the LLLL, as compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA).
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
- None
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
- •Being over 18 years old
- •Must be able to follow instructions and attend study visits.
- •Diagnosis of CHF functional class II (NYHA) without prior use of diuretics
- •Women of childbearing potential who are using a reliable contraceptive method, as assessed by the principal investigator
排除标准
- •Any clinically significant, serious or severe medical condition (e.g., Thyroid, renal or liver disorder, Chronic Obstructive Pulmonary Disease, etc.)
- •History of acute myocardial infarction (within 6 months) or decompensated coronary artery disease
- •Pulmonary hypertension - PASP > 45 mmHg
- •Fasting blood glucose above 150 mg/dl
- •Psychiatric or neurological disorders
- •A condition that, according to Principal Investigator's opinion, may interfere with the optimal study participation or which may put the patient at special risk.
- •Participation in any other investigational study within 12 months before signing the ICF.
- •Known medical history of allergy, hypersensitivity or intolerance to any of the components of the drugs to be used in this study.
- •Any medical treatment that is unrelated to the study and scheduled to the clinical trial period, except for non-serious well-controlled comorbidities which are already being followed up medically.
- •Another drug scheduled to be initiated after study entry.
- •Obesity - BMI > 30 kg/m2
- •Pregnancy and lactation
研究组 & 干预措施
furosemide (40 mg) +amiloride (10 mg)
One group of patients will receive furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow the tablet in whole form on an empty stomach with some liquid.
干预措施: Diurisa® (Drug)
Lasix ®
One group of patients will receive Lasix® (furosemide 40 mg). For treatment, the patient will swallow the tablet in whole form on an empty stomach with some liquid.
干预措施: Lasix ® (Drug)
结局指标
主要结局
Evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
时间窗: 5 months
General physical examination and measure of potassium level in blood will be used for measuring the improvement of CHF symptoms and decrease in peripheral edema. The exams will be performed before the enrollment in the clinical study and every 7 days. Patients who have potassium levels below normal (normal K+ ≥ 3.5 mEq/l) after visit 2 may receive oral replacement, at the investigator's discretion, pursuant to the study site routine. The final evaluation will be performed 42 days after the inclusion of the last patient.
次要结局
未报告次要终点