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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Withdrawn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 spironolactone
Drug: metolazone/no spironolactone
Drug: furosemid/spironolactone
Drug: 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WITHDRAWN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
  1. dyspnea at rest or minimal activity
  2. tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
  3. who need diuretics add over 40mg of daily furosemide dose
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Exclusion Criteria
  1. Hospitalization for acute heart failure decompensation
  2. cardiogenic shock (Systolic Blood Pressure < 80mmHg)
  3. Need or plan for renal replacement therapy (dialysis, kidney transplant)
  4. serum creatine level > 2.5mg/dl
  5. serum potassium (K+) > 5.5mg/dl
  6. daily spironolactone dose > 50mg
  7. previous thiazide or metolazone user
  8. 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
GroupInterventionDescription
1) Add furosemide/no spironolactonefurosemide/no spironolactone-
2) Add metolazone/no spironolactonemetolazone/no spironolactone-
3) Add furosemide/spironolactonefurosemid/spironolactone-
4) Add metolazone/spironolactonemetolazone/spironolactone-
Primary Outcome Measures
NameTimeMethod
efficacy and safety of diuretics add-on strategyD+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
NameTimeMethod
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