Back to resultsA 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)
Primary Purpose
Congestive Heart Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
furosemide/no spironolactone
metolazone/no spironolactone
furosemid/spironolactone
metolazone/spironolactone
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart failure, diuretics, kidney, glomerular filtration rate
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
- cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1) Add furosemide/no spironolactone
2) Add metolazone/no spironolactone
3) Add furosemide/spironolactone
4) Add metolazone/spironolactone
Arm Description
Outcomes
Primary Outcome Measures
efficacy and safety of diuretics add-on strategy
1) body weight change, symptoms & signs change, systemic impedance change 2) serum & urine creatinine change, serum & urine electrolyte change, biomarkers change, clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01817803
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart failure, diuretics, kidney, glomerular filtration rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1) Add furosemide/no spironolactone
Arm Type
Active Comparator
Arm Title
2) Add metolazone/no spironolactone
Arm Type
Active Comparator
Arm Title
3) Add furosemide/spironolactone
Arm Type
Active Comparator
Arm Title
4) Add metolazone/spironolactone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
furosemide/no spironolactone
Intervention Description
furosemide (doubling previous furosemide dose)
Intervention Type
Drug
Intervention Name(s)
metolazone/no spironolactone
Intervention Description
metolazone (add 2.5mg qod)
Intervention Type
Drug
Intervention Name(s)
furosemid/spironolactone
Intervention Description
furosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
Intervention Type
Drug
Intervention Name(s)
metolazone/spironolactone
Intervention Description
metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
Primary Outcome Measure Information:
Title
efficacy and safety of diuretics add-on strategy
Description
1) body weight change, symptoms & signs change, systemic impedance change 2) serum & urine creatinine change, serum & urine electrolyte change, biomarkers change, clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)
Time Frame
D+0, D+7, D+30, D+90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
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
cardiogenic shock (Systolic Blood Pressure < 80mmHg)
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
12. IPD Sharing Statement
Learn more about this trial
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)
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