Recombinant BNP on Heart and Renal Function in Acute Heart Failure

NCT ID: NCT01625403

Last Updated: 2012-08-07

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of recombinant human B-type natriuretic peptide (rhBNP) on heart and renal function in patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI).

Detailed Description

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Patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI) will be randomized to receive standard of care with or without additional rhBNP.

Clinical heart function, LVEF, SCr, GFR and other laboratory parameters will be evaluated.

Conditions

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Acute Heart Failure Acute Renal Failure

Keywords

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Recombinant BNP Diuretics Acute decompensated heart failure Acute renal injury Heart function Renal function

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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rhBNP treated

standard of care with rhBNP

Group Type EXPERIMENTAL

rhBNP

Intervention Type DRUG

intravenous administration of rhBNP 0.01 µg/kg/min

standard of care

standard of care

Group Type ACTIVE_COMPARATOR

standard of care

Intervention Type DRUG

standard of care for heart failure

Interventions

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rhBNP

intravenous administration of rhBNP 0.01 µg/kg/min

Intervention Type DRUG

standard of care

standard of care for heart failure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* acute heart failure with acute renal injury

Exclusion Criteria

* not tolerate to rhBNP
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fang Yuan

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang Yuan

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Yuan

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fang Yuan

Role: primary

Other Identifiers

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SHCHESTCCU01

Identifier Type: -

Identifier Source: org_study_id