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Recombinant BNP on Heart and Renal Function in Acute Heart Failure

Primary Purpose

Acute Heart Failure, Acute Renal Failure

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rhBNP
standard of care
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Recombinant BNP, Diuretics, Acute decompensated heart failure, Acute renal injury, Heart function, Renal function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute heart failure with acute renal injury

Exclusion Criteria:

  • not tolerate to rhBNP

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rhBNP treated

standard of care

Arm Description

standard of care with rhBNP

standard of care

Outcomes

Primary Outcome Measures

left ventricular systolic function

Secondary Outcome Measures

serum creatinine

Full Information

First Posted
June 19, 2012
Last Updated
August 5, 2012
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01625403
Brief Title
Recombinant BNP on Heart and Renal Function in Acute Heart Failure
Official Title
Effect of Recombinant BNP on Heart and Renal Function in Acute Decompensated Heart Failure Patients With Acute Renal Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Acute Renal Failure
Keywords
Recombinant BNP, Diuretics, Acute decompensated heart failure, Acute renal injury, Heart function, Renal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rhBNP treated
Arm Type
Experimental
Arm Description
standard of care with rhBNP
Arm Title
standard of care
Arm Type
Active Comparator
Arm Description
standard of care
Intervention Type
Drug
Intervention Name(s)
rhBNP
Intervention Description
intravenous administration of rhBNP 0.01 µg/kg/min
Intervention Type
Drug
Intervention Name(s)
standard of care
Intervention Description
standard of care for heart failure
Primary Outcome Measure Information:
Title
left ventricular systolic function
Time Frame
90 days
Secondary Outcome Measure Information:
Title
serum creatinine
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute heart failure with acute renal injury Exclusion Criteria: not tolerate to rhBNP
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Yuan
Email
yuanfangysh@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Yuan
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Yuan
Email
yuanfangysh@126.com
First Name & Middle Initial & Last Name & Degree
Fang Yuan

12. IPD Sharing Statement

Learn more about this trial

Recombinant BNP on Heart and Renal Function in Acute Heart Failure

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