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)

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01817803
• Other study ID #: 4-2013-0013
• Status: Withdrawn
• Phase: N/A
• First received: March 20, 2013
• Last updated: February 17, 2014
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• 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• Status: Withdrawn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: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 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

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

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/no spironolactone
furosemide (doubling previous furosemide dose)
• metolazone/no spironolactone
metolazone (add 2.5mg qod)
• furosemid/spironolactone
furosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
• metolazone/spironolactone
metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID 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
Primary	efficacy and safety of diuretics add-on strategy	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)	D+0, D+7, D+30, D+90	No