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)

NCT02047422 — Not applicable, Withdrawn, Yonsei University

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Registry	NCT02047422
Status	Withdrawn - One of the diuretic which is planned to be used in the study is no longer available.
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Sponsor	Yonsei University (Other)
Conditions	Congestive Heart Failure
Interventions	Furosemide, metolazone, furosemid/spironolactone, metolazone/spironolactone (Drug)
Dates	start 2014-01-01, primary completion 2016-02-01 (estimated), completion 2016-02-01 (estimated), first posted 2014-01-28, last updated 2016-09-07

-Summary

To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients

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+Arms and interventions

Arm	Type	Interventions
Add furosemide/no spironolactone	Experimental	Drug: Furosemide
Add metolazone/no spironolactone	Experimental	Drug: metolazone
Add furosemid/spironolactone	Experimental	Drug: furosemid/spironolactone
Add metolazone/spironolactone	Experimental	Drug: metolazone/spironolactone

Furosemide (Drug): furosemide (doubling previous furosemide dose)
metolazone (Drug): metolazone (add 2.5mg qod)
furosemid/spironolactone (Drug): spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
metolazone/spironolactone (Drug): no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)

+Outcome measures

Primary outcomes

urine output change [from admission to Hospital Day (HOD)#4]: efficacy of diuretics add-on therapy, urine output change

Secondary outcomes

serum creatinine change [from admission to HOD#4]: safety of diuretics add-on therapy, serum creatinine change

Other outcomes

body weight change [from admission to HOD#4]: body weight change, symptoms \& signs change
urine creatinine change [from admission to HOD#4]: urine creatinine change, serum \& urine electrolyte change, biomarkers change
clinical outcomes [at 90 days after discharge]: clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)

+Eligibility

Sex: All, ages: 20 Years to 80 Years

Inclusion Criteria:

1. dyspnea at rest or minimal activity
2. tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray

Exclusion Criteria:

1. hospitalization for acute heart failure decompensation
2. cardiogenic shock (Systolic Blood Pressure < 80mmHg)
3. Need or plan for renal replacement therapy (dialysis, kidney transplant)
4. serum creatine level > 2.5mg/dl
5. serum potassium (K+) > 5.5mg/dl
6. Age > 80 years old or poor compliance patients
7. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
8. life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis)
9. pregnancy or women at age of childbearing potential