Recombinant BNP on Heart and Renal Function in Acute Heart Failure

Phase 2

• Conditions: Acute Heart Failure; Acute Renal Failure
• Interventions: Drug: standard of care; Drug: rhBNP

• Registration Number: NCT01625403
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Study Start: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-05
• Last Update Posted: 2012-08-07
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• acute heart failure with acute renal injury

Exclusion Criteria

• not tolerate to rhBNP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard of care	standard of care	standard of care
rhBNP treated	rhBNP	standard of care with rhBNP

Primary Outcome Measures

Name	Time	Method
left ventricular systolic function	90 days

Secondary Outcome Measures

Name	Time	Method
serum creatinine	90 days

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China