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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)

Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congestive Heart Failure

Intervention: furosemide/no spironolactone (Drug); metolazone/no spironolactone (Drug); furosemid/spironolactone (Drug); metolazone/spironolactone (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Yonsei University


To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: efficacy and safety of diuretics add-on strategy


Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.


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 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

Locations and Contacts

Additional Information

Starting date: March 2013
Last updated: February 17, 2014

Page last updated: August 23, 2015

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