NCT01817803WithdrawnNot Applicable
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Yonsei University
- Primary Endpoint
- efficacy and safety of diuretics add-on strategy
Study Overview
Brief Summary
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
- •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
Arms & Interventions
1) Add furosemide/no spironolactone
Active Comparator
Intervention: furosemide/no spironolactone (Drug)
2) Add metolazone/no spironolactone
Active Comparator
Intervention: metolazone/no spironolactone (Drug)
3) Add furosemide/spironolactone
Active Comparator
Intervention: furosemid/spironolactone (Drug)
4) Add metolazone/spironolactone
Active Comparator
Intervention: metolazone/spironolactone (Drug)
Outcomes
Primary Outcomes
efficacy and safety of diuretics add-on strategy
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
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