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)
Not Applicable
Withdrawn
- Conditions
- Congestive Heart Failure
- Interventions
- Registration Number
- NCT02047422
- Lead Sponsor
- Yonsei University
- Brief Summary
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- dyspnea at rest or minimal activity
- tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
Exclusion Criteria
- 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
- Age > 80 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Add furosemid/spironolactone furosemid/spironolactone - Add metolazone/spironolactone metolazone/spironolactone - Add metolazone/no spironolactone metolazone - Add furosemide/no spironolactone Furosemide -
- Primary Outcome Measures
Name Time Method urine output change from admission to Hospital Day (HOD)#4 efficacy of diuretics add-on therapy, urine output change
- Secondary Outcome Measures
Name Time Method serum creatinine change from admission to HOD#4 safety of diuretics add-on therapy, serum creatinine change