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NCT01625403 Clinical Trial

Recombinant BNP on Heart and Renal Function in Acute Heart Failure

Acute Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01625403
Other study ID # SHCHESTCCU01
Secondary ID
Status Recruiting
Phase Phase 2
First received June 19, 2012
Last updated August 5, 2012
Start date July 2012
Est. completion date December 2013

Study information
Verified date August 2012
Source Shanghai Chest Hospital
Contact Fang Yuan
Email yuanfangysh@126.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- acute heart failure with acute renal injury

Exclusion Criteria:

- not tolerate to rhBNP

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rhBNP
intravenous administration of rhBNP 0.01 µg/kg/min
• standard of care
standard of care for heart failure

Locations
Country Name City State
China Shanghai Chest Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary left ventricular systolic function 90 days No
Secondary serum creatinine 90 days Yes
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