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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Myocardiopathies; Heart Decompensation; Systolic or Diastolic Left Ventricular Dysfunction; Heart Failure, Congestive; Left Ventricular Failure

Treatments: Drug: Placebo; Drug: Carperitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259038

03-0-162

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups, including a placebo group

Experimental Drug

Experimental group

Treatment:

Drug: Carperitide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo