Sarcoidosis-associated Pulmonary Hypertension

SARCOIDOSIS Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139710
• Other study ID #: MMC10-114-10.CTIL
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: March 12, 2013
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

This prospective study was conducted to explore clinical characteristics and outcomes of patients diagnosed with pulmonary sarcoidosis and PH. The investigators also assessed the role of D -dimer levels in these population.

Description:

The investigation will be approving by the Ethics Committee of Meir medical center.

We retrospectively will review the medical records of 100 sarcoidosis patients seen in our outpatient pulmonary clinics of Meir medical center, between July 2009 and May 2010.

All the patients will prospectively invite to our pulmonary outpatients clinic at Meir medical center.

Sarcoidosis will be diagnosed based on the latest American Thoracic Society (ATS), European Respiratory Society (ERS) and World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria. (6, 7) Each patient will undergo two-dimensional echocardiographic data, complete pulmonary function test results including spirometry, lung volume, CO diffusion capacity and 6-min walk test (6MWT) data and D-dimer assay during their visiting.

Data will be collecting including patient demographics, symptoms, details of comorbid illnesses, sarcoidosis stage using the modified Scadding (8) classification system to stage chest radiography (CXR) findings and treatment.

Pulmonary function tests included spirometry and lung volume measurement by body plethysmography, performed according to the recommendations of the American Thoracic Society. (9) The 6MWT was conducted in accordance with ATS guidelines. (10) All patients exhibited resting oxygen saturation (SpO 2 ) the > 88% at the beginning of the walk test and Borg dyspnea index (11) will be record at the beginning and end of the 6-min walk.

All Computed tomography (CT) findings of the patients will be assess for the presence of the following recognized CT patterns (12): (1) mediastinal and/or hilar lymph node enlargement; (2) ground-glass opacity; (3) consolidation; (4) nodules <3 cm in diameter; (5) thickening of bronchovascular bundles; (6) linear opacity, including interlobular septal lines and interstitial thickening and (7) features indicating scarring and fibrosis (grouped together) that included traction bronchiectasis, honeycombing, cysts and/or volume loss.

In addition, all CT will be review for findings that are known as a signs of PH including the pulmonary trunk diameter, right and left pulmonary arteries diameters and the pulmonary to aortic diameters ratio.

The radiologist will be blinded to the echocardiological data as well as to the pulmonary function data and D-dimer levels.

Diagnosis of PH was based on Doppler echocardiography and defined as an estimated right ventricular systolic pressure (RVSP) of the > 40 mm Hg in the absence of left ventricular dysfunction (i.e., an ejection fraction under 50%), ischemic heart disease (manifested by regional wall motion abnormalities) or valvular heart disease. Right ventricular systolic pressure was estimated based on the modified Bernoulli equation (13) RVSP = transtricuspid gradient + right atrial pressure (RAP), where transtricuspid gradient is 4v2 (v = peak velocity of tricuspid regurgitation in meter per second) and RAP was estimated to be 5, 10 All the patients will undergo a D-dimer assay in the same day of the pulmonary function tests and Echo evaluations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients above 18 years old

Exclusion Criteria:

• Non sarcoidosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Sarcoidosis

Locations

Country	Name	City	State
Israel	Meir MC	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to explore clinical characteristics and outcomes of patients diagnosed with pulmonary sarcoidosis and PH		1 year	No