NCT01625403

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

June 19, 2012

Last Update Submit

August 5, 2012

Conditions

Acute Heart FailureAcute Renal Failure

Keywords

Recombinant BNPDiureticsAcute decompensated heart failureAcute renal injuryHeart functionRenal function

Outcome Measures

Primary Outcomes (1)

  • left ventricular systolic function

    90 days

Secondary Outcomes (1)

  • serum creatinine

    90 days

Study Arms (2)

rhBNP treated

EXPERIMENTAL

standard of care with rhBNP

Drug: rhBNP

standard of care

ACTIVE COMPARATOR

standard of care

Drug: standard of care

Interventions

rhBNPDRUG

intravenous administration of rhBNP 0.01 µg/kg/min

rhBNP treated
standard of careDRUG

standard of care for heart failure

standard of care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute heart failure with acute renal injury

You may not qualify if:

  • not tolerate to rhBNP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Fang Yuan

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Yuan

CONTACT

yuanfangysh@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

CN(1)