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Sarcoidosis-associated Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01139710
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date June 7, 2010
First Posted Date June 8, 2010
Last Update Posted Date March 13, 2013
Study Start Date October 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2013)
to explore clinical characteristics and outcomes of patients diagnosed with pulmonary sarcoidosis and PH [ Time Frame: 1 year ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sarcoidosis-associated Pulmonary Hypertension
Official Title Not Provided
Brief 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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 100 sarcoidosis patients
Condition SARCOIDOSIS
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2013)
75
Original Estimated Enrollment
 (submitted: June 7, 2010)
100
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients above 18 years old

Exclusion Criteria:

  • Non sarcoidosis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01139710
Other Study ID Numbers MMC10-114-10.CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date July 2011