Recombinant BNP on Heart and Renal Function in Acute Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Shanghai Chest Hospital
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
  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
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
Other Name: rhBNP
Active Comparator: standard of care
standard of care
Drug: standard of care
standard of care for heart failure
Other Name: standard of care

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

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

Inclusion Criteria:

  • acute heart failure with acute renal injury

Exclusion Criteria:

  • not tolerate to rhBNP
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Fang Yuan, Dr., Shanghai Chest Hospital
ClinicalTrials.gov 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
Diuretics
Acute decompensated heart failure
Acute renal injury
Heart function
Renal function

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

ClinicalTrials.gov processed this record on August 01, 2014