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)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02047422

Enrollment

Registered

2014-01-28

Start date

2014-01-31

Completion date

2016-02-29

Last updated

2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

Heart failure, diuretics, kidney, glomerular filtration rate

Brief summary

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

Interventions

DRUGFurosemide

furosemide (doubling previous furosemide dose)

DRUGmetolazone

metolazone (add 2.5mg qod)

DRUGfurosemid/spironolactone

spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)

DRUGmetolazone/spironolactone

no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
urine output change	from admission to Hospital Day (HOD)#4	efficacy of diuretics add-on therapy, urine output change

Secondary

Measure	Time frame	Description
serum creatinine change	from admission to HOD#4	safety of diuretics add-on therapy, serum creatinine change

Other

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026