Back to resultsA 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)
Primary Purpose
Congestive Heart Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Furosemide
metolazone
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
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
- Age > 80 years old or poor compliance patients
- allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
- life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis)
- pregnancy or women at age of childbearing potential
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Add furosemide/no spironolactone
Add metolazone/no spironolactone
Add furosemid/spironolactone
Add metolazone/spironolactone
Arm Description
Outcomes
Primary Outcome Measures
urine output change
efficacy of diuretics add-on therapy, urine output change
Secondary Outcome Measures
serum creatinine change
safety of diuretics add-on therapy, serum creatinine change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02047422
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
One of the diuretic which is planned to be used in the study is no longer available.
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
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
Add furosemide/no spironolactone
Arm Type
Experimental
Arm Title
Add metolazone/no spironolactone
Arm Type
Experimental
Arm Title
Add furosemid/spironolactone
Arm Type
Experimental
Arm Title
Add metolazone/spironolactone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
furosemide (doubling previous furosemide dose)
Intervention Type
Drug
Intervention Name(s)
metolazone
Intervention Description
metolazone (add 2.5mg qod)
Intervention Type
Drug
Intervention Name(s)
furosemid/spironolactone
Intervention Description
spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
Intervention Type
Drug
Intervention Name(s)
metolazone/spironolactone
Intervention Description
no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)
Primary Outcome Measure Information:
Title
urine output change
Description
efficacy of diuretics add-on therapy, urine output change
Time Frame
from admission to Hospital Day (HOD)#4
Secondary Outcome Measure Information:
Title
serum creatinine change
Description
safety of diuretics add-on therapy, serum creatinine change
Time Frame
from admission to HOD#4
Other Pre-specified Outcome Measures:
Title
body weight change
Description
body weight change, symptoms & signs change
Time Frame
from admission to HOD#4
Title
urine creatinine change
Description
urine creatinine change, serum & urine electrolyte change, biomarkers change
Time Frame
from admission to HOD#4
Title
clinical outcomes
Description
clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)
Time Frame
at 90 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 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
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
Age > 80 years old or poor compliance patients
allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis)
pregnancy or women at age of childbearing potential
12. IPD Sharing Statement
Learn more about this trial
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)
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