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

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ClinicalTrials.gov Identifier: NCT00675051
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Pulmonary Hypertension

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Endothelin-1 Receptor Blockade on Circulating Endothelial Microparticles Levels in Patients With Pulmonary Hypertension
Study Start Date : March 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675051


Locations
United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
More Information

Responsible Party: Yerem Yeghiazarians, Professor of Clinical Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00675051     History of Changes
Other Study ID Numbers: H47369-31390
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by Yerem Yeghiazarians, 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

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases