CompletedInterventionalPhase 4Updated May 21, 2019
A Prospective, Single-center, Open-label, Pilot Study to Compare the Effectiveness and Safety of Diuretics Add-On Strategy in Chronic Heart... | NCT01817803 | Trialant
WithdrawnInterventionalNot ApplicableUpdated Feb 19, 2014
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)
ClinicalTrials.gov ID
NCT01817803
Lead Sponsor
Yonsei UniversityOTHER
Overall Status
Withdrawn
Study Type
Interventional
Phase
Not Applicable
Enrollment
0Actual
Last Update Posted
Feb 19, 2014Estimated
Start Date
Mar 2013
Primary Completion Date
Jun 2015Estimated
Completion Date
Dec 2015Estimated
Brief Summary
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
Congestive Heart Failure
furosemide/no spironolactone
metolazone/no spironolactone
furosemid/spironolactone
metolazone/spironolactone
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 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