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 University

Status: Withdrawn

Conditions: Congestive Heart Failure

Treatments: Drug: metolazone; Drug: metolazone/spironolactone; Drug: furosemid/spironolactone; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT02047422

4-2013-0808

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 80 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

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

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

Add furosemide/no spironolactone

Experimental group

Treatment:

Drug: Furosemide

Add metolazone/no spironolactone

Experimental group

Treatment:

Drug: metolazone

Add furosemid/spironolactone

Experimental group

Treatment:

Drug: furosemid/spironolactone

Add metolazone/spironolactone

Experimental group

Treatment:

Drug: metolazone/spironolactone