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Clinical Trials/NCT02047422
NCT02047422
Withdrawn
Not Applicable

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)

Yonsei University0 sitesJanuary 2014

Overview

Phase
Not Applicable
Intervention
Furosemide
Conditions
Congestive Heart Failure
Sponsor
Yonsei University
Primary Endpoint
urine output change
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
February 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Add furosemide/no spironolactone

Intervention: Furosemide

Add metolazone/no spironolactone

Intervention: metolazone

Add furosemid/spironolactone

Intervention: furosemid/spironolactone

Add metolazone/spironolactone

Intervention: metolazone/spironolactone

Outcomes

Primary Outcomes

urine output change

Time Frame: 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)

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