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)
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 Mar 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 19, 2014
February 1, 2014
2.3 years
March 20, 2013
February 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
D+0, D+7, D+30, D+90
Study Arms (4)
1) Add furosemide/no spironolactone
ACTIVE COMPARATOR2) Add metolazone/no spironolactone
ACTIVE COMPARATOR3) Add furosemide/spironolactone
ACTIVE COMPARATOR4) Add metolazone/spironolactone
ACTIVE COMPARATORInterventions
furosemide (doubling previous furosemide dose)
furosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID 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
- who need diuretics add over 40mg of daily furosemide dose
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
- 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
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
March 20, 2013
First Posted
March 25, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
February 19, 2014
Record last verified: 2014-02