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)

Not Applicable

Withdrawn

• Conditions: Congestive Heart Failure
• Interventions: Drug: furosemid/spironolactone; Drug: metolazone/spironolactone; Drug: metolazone; Drug: Furosemide

• Registration Number: NCT02047422
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-26
• Study First Posted: 2014-01-28
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-05
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Add furosemid/spironolactone	furosemid/spironolactone	-
Add metolazone/spironolactone	metolazone/spironolactone	-
Add metolazone/no spironolactone	metolazone	-
Add furosemide/no spironolactone	Furosemide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
serum creatinine change	from admission to HOD#4	safety of diuretics add-on therapy, serum creatinine change