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)
Not Applicable
Withdrawn
- Conditions
- Congestive Heart Failure
- Interventions
- Drug: furosemide/no spironolactoneDrug: metolazone/no spironolactoneDrug: furosemid/spironolactoneDrug: metolazone/spironolactone
- Registration Number
- NCT01817803
- 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- WITHDRAWN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
- who need diuretics add over 40mg of daily furosemide dose
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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
- daily spironolactone dose > 50mg
- previous thiazide or metolazone user
- Age > 75 years old or poor compliance patients 9. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics 10. life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis) 11. pregnancy or women at age of childbearing potential
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1) Add furosemide/no spironolactone furosemide/no spironolactone - 2) Add metolazone/no spironolactone metolazone/no spironolactone - 3) Add furosemide/spironolactone furosemid/spironolactone - 4) Add metolazone/spironolactone metolazone/spironolactone -
- Primary Outcome Measures
Name Time Method efficacy and safety of diuretics add-on strategy 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)
- Secondary Outcome Measures
Name Time Method