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)

Yonsei University

Status: Withdrawn

Conditions: Congestive Heart Failure

Treatments: Drug: furosemid/spironolactone; Drug: metolazone/no spironolactone; Drug: metolazone/spironolactone; Drug: furosemide/no spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT01817803

4-2013-0013

Details and patient eligibility

About

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

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

1) Add furosemide/no spironolactone

Active Comparator group

Treatment:

Drug: furosemide/no spironolactone

2) Add metolazone/no spironolactone

Active Comparator group

Treatment:

Drug: metolazone/no spironolactone

3) Add furosemide/spironolactone

Active Comparator group

Treatment:

Drug: furosemid/spironolactone

4) Add metolazone/spironolactone

Active Comparator group

Treatment:

Drug: metolazone/spironolactone