Clinical trial NCT00259038: Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure
Official title: A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure, Congestive
Heart Decompensation
Left Ventricular Failure
Myocardiopathies
Systolic or Diastolic Left Ventricular Dysfunction
Keywords: Carperitide
Atrial Natriuretic Peptide
Treatment efficacy
Safety
Heart failure, Congestive
Pulmonary Artery Catheterization
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in pulmonary capillary wedge pressure (PCWP)
timeFrame: at 3 hours following initiation of study drug infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Bay Pines
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Covington
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: St Louis
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Amarillo
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: St Foy
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Biljana Pavlovic-Surjancev, MD, PhD
role: STUDY_DIRECTOR
References: