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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 Dr. Fang Yuan, Shanghai Chest Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625403
First Posted: June 21, 2012
Last Update Posted: August 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Fang Yuan, Shanghai Chest Hospital
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 Dr. Fang Yuan, Shanghai Chest Hospital:

Primary Outcome Measures:
  • left ventricular systolic function [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • serum creatinine [ Time Frame: 90 days ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute heart failure with acute renal injury

Exclusion Criteria:

  • not tolerate to rhBNP
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625403


Contacts
Contact: Fang Yuan yuanfangysh@126.com

Locations
China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Fang Yuan       yuanfangysh@126.com   
Principal Investigator: Fang Yuan         
Sponsors and Collaborators
Shanghai Chest Hospital
Investigators
Principal Investigator: Fang Yuan Shanghai Chest Hospital
  More Information

Responsible Party: Dr. Fang Yuan, Dr., Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT01625403     History of Changes
Other Study ID Numbers: SHCHESTCCU01
First Submitted: June 19, 2012
First Posted: June 21, 2012
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by Dr. Fang Yuan, Shanghai Chest Hospital:
Recombinant BNP
Diuretics
Acute decompensated heart failure
Acute renal injury
Heart function
Renal function

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Acute Kidney Injury
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases