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

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.

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Key information

Conditions

Heart Failure, Congestive Cardiomyopathies Cardiovascular Diseases Heart Decompensation Heart Diseases Heart Failure Heart Murmurs Left Ventricular Failure Myocardiopathies Pathological Conditions, Signs and Symptoms Signs and Symptoms Systolic Murmurs Systolic or Diastolic Left Ventricular Dysfunction Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Halifax, Nova Scotia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carperitide

Drug

Other names: human recombinant atrial natriuretic peptide

Placebo

Drug

Primary outcomes

Change from baseline in pulmonary capillary wedge pressure (PCWP)

Time frame: at 3 hours following initiation of study drug infusion

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Nov 29, 2005
Registry last updated: Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed