Recombinant BNP on Heart and Renal Function in Acute Heart Failure
This study is currently recruiting participants.
Verified August 2012 by Shanghai Chest Hospital
Sponsor:
Shanghai Chest Hospital
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
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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
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 May 16, 2013