Recombinant BNP on Heart and Renal Function in Acute Heart Failure

Sponsor

Shanghai Chest Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01625403

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure Acute Renal Failure	Drug: rhBNP Drug: standard of care	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rhBNP treated standard of care with rhBNP	Drug: rhBNP intravenous administration of rhBNP 0.01 µg/kg/min
Active Comparator: standard of care standard of care	Drug: standard of care standard of care for heart failure

Arm

Intervention/Treatment

Experimental: rhBNP treated

standard of care with rhBNP

Drug: rhBNP

intravenous administration of rhBNP 0.01 µg/kg/min

Active Comparator: standard of care

standard of care

Drug: standard of care

standard of care for heart failure

Outcome Measures

Primary Outcome Measures

left ventricular systolic function [90 days]

Secondary Outcome Measures

serum creatinine [90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

acute heart failure with acute renal injury

Exclusion Criteria:

not tolerate to rhBNP

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Chest Hospital	Shanghai	Shanghai	China	200030

Sponsors and Collaborators

Shanghai Chest Hospital

Investigators

Principal Investigator: Fang Yuan, Shanghai Chest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Fang Yuan, Dr., Shanghai Chest Hospital

ClinicalTrials.gov Identifier:

NCT01625403

Other Study ID Numbers:

SHCHESTCCU01

First Posted:

Jun 21, 2012

Last Update Posted:

Aug 7, 2012

Last Verified:

Aug 1, 2012

Keywords provided by Dr. Fang Yuan, Dr., Shanghai Chest Hospital

Recombinant BNP

Diuretics

Acute decompensated heart failure

Acute renal injury

Heart function

Renal function

Additional relevant MeSH terms:

Acute Kidney Injury

Heart Failure

Study Results

No Results Posted as of Aug 7, 2012