NCT01817803撤回不适用
A Prospective, Single-center, Open-label, Pilot Study to Compare the Effectiveness and Safety of Diuretics Add-On Strategy in Chronic Heart Failure Patients (DIOS 1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- efficacy and safety of diuretics add-on strategy
研究概览
简要总结
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dyspnea at rest or minimal activity
- •tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
- •who need diuretics add over 40mg of daily furosemide dose
排除标准
- •Hospitalization for acute heart failure decompensation
- •cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- •Need or plan for renal replacement therapy (dialysis, kidney transplant)
- •serum creatine level > 2.5mg/dl
- •serum potassium (K+) > 5.5mg/dl
- •daily spironolactone dose > 50mg
- •previous thiazide or metolazone user
- •Age > 75 years old or poor compliance patients
- •allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
- •life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis)
- •pregnancy or women at age of childbearing potential
研究组 & 干预措施
1) Add furosemide/no spironolactone
Active Comparator
干预措施: furosemide/no spironolactone (Drug)
2) Add metolazone/no spironolactone
Active Comparator
干预措施: metolazone/no spironolactone (Drug)
3) Add furosemide/spironolactone
Active Comparator
干预措施: furosemid/spironolactone (Drug)
4) Add metolazone/spironolactone
Active Comparator
干预措施: metolazone/spironolactone (Drug)
结局指标
主要结局
efficacy and safety of diuretics add-on strategy
时间窗: D+0, D+7, D+30, D+90
1) body weight change, symptoms \& signs change, systemic impedance change 2) serum \& urine creatinine change, serum \& urine electrolyte change, biomarkers change, clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)
次要结局
未报告次要终点
研究者
相似试验
撤回
不适用
A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Compare the Effectiveness and Safety of DIuretics Add-On Strategy in Acute Decompensated Heart Failure Patients (DIOS II)Congestive Heart FailureNCT02047422Yonsei University
已完成
4 期
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium AssessmentDiuretics Drug ReactionsAcute Heart FailureNCT05411991Vrije Universiteit Brussel107
撤回
4 期
Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes MellitusHF - Heart FailureDiabetes MellitusNCT04697485Northwestern University
Unknown
4 期
Evaluating Iron Protein Succinylate Oral Solution in Treating Chronic Heart Failure and Iron DeficiencyIron-deficiencyChronic Heart FailureNCT03344523Lee's Pharmaceutical Limited600
终止
4 期
Diuretic Strategies in Acute Heart Failure Patients At High Risk for Diuretic ResistanceDiuretic ResistanceAcute Heart FailureNCT05986773Stadtspital Zürich13