Effect of Endothelin-1 Receptor Blockade on Circulating Endothelial Microparticles Levels in Patients With Pulmonary Hypertension

This study is currently recruiting participants.

Verified by University of California, San Francisco, March 2008

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00675051

Purpose

Pulmonary hypertension is a progressive and life threatening condition. It is characterized by severe remodeling of the pulmonary vessel wall, obstructive plexiform lesions, multi-focal thrombosis, and enhanced vasoconstriction. All of these characteristics contribute to increased pulmonary vascular resistance.

Circulating endothelial microparticles (EMPs) play an integral role in the pathogenesis and perpetuation of pulmonary hypertension. Levels of EMPs are considered a reliable biological parameter of endothelial injury.

We propose to assess the evolution of both circulating and pulmonary venous EMPs in patients with PH. Assessments will be made before and after initiation of Endothelin-1 (ET-1) Receptor blocker therapy, and correlated to their patterns with the changes in mean PAP, the 6 Minutes Walking Distance test, and circulating Endothelin-1 values. Measurements of the endothelial microparticle circulating levels (assessed by flow cytometry methods) will be made before, 1 month and 3 months after initiation of therapy.

Condition
Pulmonary Hypertension

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Effect of Endothelin-1 Receptor Blockade on Circulating Endothelial Microparticles Levels in Patients With Pulmonary Hypertension

Further study details as provided by University of California, San Francisco:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Precapillary Pulmonary Hypertension

Criteria

Inclusion Criteria:

Patient's + 18 years with suspected pre-capillary pulmonary hypertension
Prescribed Endothelial - 1 receptor blocker

Exclusion Criteria:

Currently taking endothelium-active vasodilator therapy.
Hemoglobin and / or hematocrit level blood the lower normal limit.
Left ventricle dysfunction (LVEF <50%)
LV end-diastolic pressure > 15 mmHg)
Recent history (<3 months) of pulmonary embolism
Liver failure or abnormal liver function tests; aortic or mitral regurgitation or stenosis
Current medication with endothelin-1 receptor antagonist, prostacyclin analogues or type 5 phosphodiesterase inhibitors.
Subjects with conditions known to be associated with an increase in circulating endothelial microparticle numers, such as chronic renal failure (Creatinine Clearance < 50 ml/min/m2) acute coronary syndromes and uncontrolled system hypertension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675051

Contacts

Contact: melanie Taylor, BHS

415-502-1310

Locations

United States, California
University of California	Recruiting
San Francisco, California, United States, 94143
Contact: Yerem Yeghaizarians, MD

Sponsors and Collaborators

University of California, San Francisco

More Information

Responsible Party:	UCSF ( Dr. Yerem Yeghiazarians )
Study ID Numbers:	H47369-31390
Study First Received:	May 6, 2008
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00675051
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

To determine if there is a trans-pulmonary gradient in the levels of EMPs in patients with PH
To determine if the EMPs measured at the pulmonary capillary wedge position correlates even more strongly with the severity of PH than the circulating levels
To determine if PH therapy with ET-1 receptor blocker will modify EMPs levels

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009