Recombinant BNP on Heart and Renal Function in Acute Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Shanghai Chest Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Dr. Fang Yuan, Shanghai Chest Hospital Identifier:
First received: June 19, 2012
Last updated: August 5, 2012
Last verified: August 2012
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).

Condition Intervention Phase
Acute Heart Failure
Acute Renal Failure
Drug: rhBNP
Drug: standard of care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Recombinant BNP on Heart and Renal Function in Acute Decompensated Heart Failure Patients With Acute Renal Injury

Resource links provided by NLM:

Further study details as provided by Shanghai Chest Hospital:

Primary Outcome Measures:
  • left ventricular systolic function [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum creatinine [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhBNP treated
standard of care with rhBNP
Drug: rhBNP
intravenous administration of rhBNP 0.01 µg/kg/min
Active Comparator: standard of care
standard of care
Drug: standard of care
standard of care for heart failure

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • acute heart failure with acute renal injury

Exclusion Criteria:

  • not tolerate to rhBNP
  Contacts and Locations
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Please refer to this study by its identifier: NCT01625403

Contact: Fang Yuan

China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Fang Yuan   
Principal Investigator: Fang Yuan         
Sponsors and Collaborators
Shanghai Chest Hospital
Principal Investigator: Fang Yuan Shanghai Chest Hospital
  More Information

Responsible Party: Dr. Fang Yuan, Dr., Shanghai Chest Hospital Identifier: NCT01625403     History of Changes
Other Study ID Numbers: SHCHESTCCU01 
Study First Received: June 19, 2012
Last Updated: August 5, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Chest Hospital:
Recombinant BNP
Acute decompensated heart failure
Acute renal injury
Heart function
Renal function

Additional relevant MeSH terms:
Acute Kidney Injury
Heart Failure
Cardiovascular Diseases
Heart Diseases
Kidney Diseases
Renal Insufficiency
Urologic Diseases processed this record on May 26, 2016