Recombinant BNP on Heart and Renal Function in Acute Heart Failure

August 5, 2012 updated by: Dr. Fang Yuan, Shanghai Chest Hospital

Effect of Recombinant BNP on Heart and Renal Function in Acute Decompensated Heart Failure Patients With Acute Renal Injury

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Principal Investigator:
          • Fang Yuan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute heart failure with acute renal injury

Exclusion Criteria:

  • not tolerate to rhBNP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard of care
Drug: standard of care
standard of care for heart failure
Experimental: rhBNP treated
standard of care with rhBNP
Drug: rhBNP
intravenous administration of rhBNP 0.01 µg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
left ventricular systolic function
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
serum creatinine
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Investigators

  • Principal Investigator: Fang Yuan, Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 5, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCHESTCCU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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