Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure

Phase 2

Completed

• Conditions: Left Ventricular Failure; Heart Failure, Congestive; Heart Decompensation; Myocardiopathies; Systolic or Diastolic Left Ventricular Dysfunction
• Interventions: Drug: Placebo; Drug: Carperitide

• Registration Number: NCT00259038
• Lead Sponsor: Daiichi Sankyo

Brief Summary

The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Is hospitalized with congestive heart failure (CHF)
• Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher

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Exclusion Criteria

• Has had a heart transplant
• Requires mechanical ventilation or mechanical circulatory support

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Experimental Drug	Carperitide	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in pulmonary capillary wedge pressure (PCWP)	at 3 hours following initiation of study drug infusion