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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)

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 (Drug); metolazone (Drug); furosemid/spironolactone (Drug); metolazone/spironolactone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Yonsei University

Overall contact:
Seok-Min Kang, MD, Phone: 82-2-2228-8450, Email: smkang@yuhs.ac

Summary

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: urine output change

Secondary outcome: serum creatinine change

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. dyspnea at rest or minimal activity 2. tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray 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. 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

Locations and Contacts

Seok-Min Kang, MD, Phone: 82-2-2228-8450, Email: smkang@yuhs.ac

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul 120-752, Korea, Republic of; Recruiting
Seok-Min Kang, MD, Phone: 82-2-2228-8450, Email: smkang@yuhs.ac
Additional Information

Starting date: January 2014
Last updated: January 26, 2014

Page last updated: August 23, 2015

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