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)
NCT ID: NCT02047422
Last Updated: 2016-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-01-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Add furosemide/no spironolactone
Furosemide
furosemide (doubling previous furosemide dose)
Add metolazone/no spironolactone
metolazone
metolazone (add 2.5mg qod)
Add furosemid/spironolactone
furosemid/spironolactone
spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
Add metolazone/spironolactone
metolazone/spironolactone
no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)
Interventions
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Furosemide
furosemide (doubling previous furosemide dose)
metolazone
metolazone (add 2.5mg qod)
furosemid/spironolactone
spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
metolazone/spironolactone
no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)
Eligibility Criteria
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Inclusion Criteria
2. tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray
Exclusion Criteria
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. Age \> 80 years old or poor compliance patients
7. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
8. life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis)
9. pregnancy or women at age of childbearing potential
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Other Identifiers
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4-2013-0808
Identifier Type: -
Identifier Source: org_study_id
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