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)

NCT ID: NCT02047422

Last Updated: 2016-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-02-29

Brief Summary

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

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Add furosemide/no spironolactone

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

furosemide (doubling previous furosemide dose)

Add metolazone/no spironolactone

Group Type EXPERIMENTAL

metolazone

Intervention Type DRUG

metolazone (add 2.5mg qod)

Add furosemid/spironolactone

Group Type EXPERIMENTAL

furosemid/spironolactone

Intervention Type DRUG

spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)

Add metolazone/spironolactone

Group Type EXPERIMENTAL

metolazone/spironolactone

Intervention Type DRUG

no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)

Interventions

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Furosemide

furosemide (doubling previous furosemide dose)

Intervention Type DRUG

metolazone

metolazone (add 2.5mg qod)

Intervention Type DRUG

furosemid/spironolactone

spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)

Intervention Type DRUG

metolazone/spironolactone

no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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4-2013-0808

Identifier Type: -

Identifier Source: org_study_id

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