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Recombinant BNP on Heart and Renal Function in Acute Heart Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Shanghai Chest Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Fang Yuan, Shanghai Chest Hospital
ClinicalTrials.gov Identifier:
NCT01625403
First received: June 19, 2012
Last updated: August 5, 2012
Last verified: August 2012

June 19, 2012
August 5, 2012
July 2012
December 2013   (final data collection date for primary outcome measure)
left ventricular systolic function [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01625403 on ClinicalTrials.gov Archive Site
serum creatinine [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Recombinant BNP on Heart and Renal Function in Acute Heart Failure
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Heart Failure
  • Acute Renal Failure
  • Drug: rhBNP
    intravenous administration of rhBNP 0.01 µg/kg/min
  • Drug: standard of care
    standard of care for heart failure
  • Experimental: rhBNP treated
    standard of care with rhBNP
    Intervention: Drug: rhBNP
  • Active Comparator: standard of care
    standard of care
    Intervention: Drug: standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • acute heart failure with acute renal injury

Exclusion Criteria:

  • not tolerate to rhBNP
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01625403
SHCHESTCCU01
No
Not Provided
Not Provided
Dr. Fang Yuan, Shanghai Chest Hospital
Shanghai Chest Hospital
Not Provided
Principal Investigator: Fang Yuan Shanghai Chest Hospital
Shanghai Chest Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP