Study Stopped
One of the diuretic which is planned to be used in the study is no longer available.
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)
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedSeptember 7, 2016
September 1, 2016
2.1 years
January 22, 2014
September 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
urine output change
efficacy of diuretics add-on therapy, urine output change
from admission to Hospital Day (HOD)#4
Secondary Outcomes (1)
serum creatinine change
from admission to HOD#4
Other Outcomes (3)
body weight change
from admission to HOD#4
urine creatinine change
from admission to HOD#4
clinical outcomes
at 90 days after discharge
Study Arms (4)
Add furosemide/no spironolactone
EXPERIMENTALAdd metolazone/no spironolactone
EXPERIMENTALAdd furosemid/spironolactone
EXPERIMENTALAdd metolazone/spironolactone
EXPERIMENTALInterventions
spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)
Eligibility Criteria
You may qualify if:
- dyspnea at rest or minimal activity
- tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2014
First Posted
January 28, 2014
Study Start
January 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
September 7, 2016
Record last verified: 2016-09