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

NCT00675051 | Completed

• 1 other identifier: H47369-31390
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Precapillary Pulmonary Hypertension

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)