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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00675051

Enrollment

Registered

2008-05-08

Start date

2008-03-31

Completion date

2009-02-28

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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.

Countries

United States

Outcome results