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Status: Withdrawn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
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: efficacy and safety of diuretics add-on strategy
Eligibility
Minimum age: 20 Years.
Maximum age: 75 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
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
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