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)

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02047422
• Other study ID #: 4-2013-0808
• Status: Withdrawn
• Phase: N/A
• First received: January 22, 2014
• Last updated: September 5, 2016
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body weight change	body weight change, symptoms & signs change	from admission to HOD#4	No
Other	urine creatinine change	urine creatinine change, serum & urine electrolyte change, biomarkers change	from admission to HOD#4	No
Other	clinical outcomes	clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)	at 90 days after discharge	No
Primary	urine output change	efficacy of diuretics add-on therapy, urine output change	from admission to Hospital Day (HOD)#4	No
Secondary	serum creatinine change	safety of diuretics add-on therapy, serum creatinine change	from admission to HOD#4	No