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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Keywords

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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 Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yerem Yeghiazarians

Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H47369-31390

Identifier Type: -

Identifier Source: org_study_id