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)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01817803

Enrollment

Registered

2013-03-25

Start date

2013-03-31

Completion date

2015-12-31

Last updated

2014-02-19

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/no spironolactone

furosemide (doubling previous furosemide dose)

DRUGmetolazone/no spironolactone

metolazone (add 2.5mg qod)

DRUGfurosemid/spironolactone

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

DRUGmetolazone/spironolactone

metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 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 3. who need diuretics add over 40mg of daily furosemide dose

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. daily spironolactone dose \> 50mg 7. previous thiazide or metolazone user 8. 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

Design outcomes

Primary

Measure	Time frame	Description
efficacy and safety of diuretics add-on strategy	D+0, D+7, D+30, D+90	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)

Outcome results

None listed

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