Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Successful Decongestion
研究概览
简要总结
This clinical trial aims to compare the efficacy and safety of acetazolamide versus metolazone as adjunctive treatments to standard therapy in patients with acute decompensated heart failure (ADHF). ADHF is a life-threatening condition, and current treatments often involve loop diuretics to alleviate volume overload. This study will assess the added benefit of acetazolamide and metolazone in improving decongestion, reducing hospital stays, and preventing complications such as renal dysfunction or electrolyte imbalances. Participants will be randomized to receive either acetazolamide or metolazone in addition to standard diuretic therapy. The trial will evaluate primary outcomes including successful decongestion, in-hospital mortality, and length of hospital stay, with secondary outcomes focusing on renal function, electrolyte disturbances, and overall safety. The study is conducted at Bahawal Victoria Hospital, Bahawalpur, and aims to provide valuable insights into the management of ADHF, especially in the Pakistani population.
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
- •Aged 18 years or older.
- •Diagnosed with Acute Decompensated Heart Failure (ADHF), with either preserved or reduced ejection fraction (EF).
- •At least one clinical sign of volume overload, such as:
- •Pleural effusion (confirmed by chest X-ray or ultrasound).
- •Oedema or ascites (verified by abdominal ultrasonography).
- •Plasma NT-proBNP level > 1000 pg/mL or BNP level > 250 ng/mL at screening.
- •Receiving at least 40 mg of furosemide as oral maintenance therapy for at least one month prior to the study initiation.
排除标准
- •Previous use of acetazolamide or metolazone prior to the study period.
- •Known hypersensitivity or allergies to the study drugs (acetazolamide or metolazone) or their components.
- •Patients with electrolyte disturbances, especially hypokalemia.
- •End-stage renal disease requiring dialysis or GFR < 20 mL/min/1.73 m².
- •Pregnant or breastfeeding women.
- •Severe hypotension (systolic blood pressure < 90 mmHg) or other significant comorbidities like congenital cardiac illness requiring surgery.
- •Patients requiring renal replacement therapy during the hospitalization.
- •History of significant electrolyte imbalances or acid-base disturbances.
结局指标
主要结局
Successful Decongestion
时间窗: 72 hours after randomization (following 3 days of treatment with the assigned adjunct therapy).
This outcome measure assesses the resolution of clinical signs and symptoms of acute decompensated heart failure (ADHF), specifically the absence of orthopnea, reduced jugular venous distention (JVD) to \<8 cm H2O, and minimal or no peripheral edema. Successful decongestion is considered when these signs are resolved within 72 hours of intervention.
次要结局
未报告次要终点
研究者
Dr. Matiullah Azmoon
Principal Investigator
University of Health Sciences Lahore