Recombinant BNP on Heart and Renal Function in Acute Hear... | NCT01625403

Studies
Recombinant BNP on Heart and Renal Function in Acute Heart Failure

NCT01625403

Sponsor

Shanghai Chest Hospital

Status

Unknown status

Last Update Posted

Aug 7, 2012Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Acute Heart Failure
Acute Renal Failure

Interventions

rhBNP
standard of care

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Jun 20, 2012

First Posted Date

Jun 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2012

Last Update Posted Date

Aug 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rhBNP treated	Experimental	standard of care with rhBNP	Drug: rhBNP
standard of care	Active Comparator	standard of care	Drug: standard of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rhBNP	Drug	intravenous administration of rhBNP 0.01 µg/kg/min	rhBNP treated

Measure	Description	Time Frame
left ventricular systolic function		90 days

Measure	Description	Time Frame
serum creatinine		90 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute heart failure with acute renal injury

Exclusion Criteria:

not tolerate to rhBNP

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fang Yuan	Contact			yuanfangysh@126.com

Overall Officials

Name	Affiliation	Role
Fang Yuan	Shanghai Chest Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Chest Hospital	Recruiting	Shanghai	Shanghai Municipality	200030	China

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided