Pulmonary hypertension in sarcoidosis: optimizing the diagnostic approach

Recruiting

Conditions: high blood pressure in pulmonary arteries
Pulmonary Hypertension
10019280
10037454

Registration Number: NL-OMON42180

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

-Diagnosis of pulmonary sarcoidosis conforming the American Thoracic Society (ATS) criteria (confirmed by histology or cytology) or by consensus of a multidisciplinary ILD-team
-Age >18 years

Exclusion Criteria

For 3D-echocardiography:
-Pacemaker or Implantable Carioverter Defibrillator (ICD)
For IVUS and right heart catheterization:
-Right heart mass (thrombus and/or tumor)
-Patients with coagulopathy
-Tricuspid or pulmonary valve mechanical prosthesis
-Endocarditis of tricuspid or pulmonary valve
-Frequent ventricular arrhythmias
For IVUS only
-Allergy to contrast
-Glomerular Filtration Rate (GFR) <30 mL/min/1.73m2 as calculated by the Cockcroft-Gault Equation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>- Presence of PH : PH will be ruled out if there are no clinical signs of PH<br /><br>during screening, based on electrocardiography (ECG), biomarkers and TTE. If PH<br /><br>is suspected, it will be confirmed or ruled out by RHC. RHC is the gold<br /><br>standard for diagnosing PH.<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>- Mechanism and cause of sarcoidosis associated PH. Each case is evaluated by a<br /><br>multidisciplinary team consisting of a specialized pulmonologist, cardiologist<br /><br>and radiologist. Next to other investigations to rule out other causes of PH<br /><br>(sleeping study, laboratory testing etc) based on the current guidelines, the<br /><br>IVUS and pressure and flow wire will be used to evaluate the mechanism of<br /><br>disease by measuring pulsatility and local pressure/flow differences<br /><br><br /><br>Other study parameters<br /><br>- Prediction of PH in pulmonary sarcoidosis : The third aim of this study is to<br /><br>find predictors for the presence of PH using non-invasive diagnostics obtained<br /><br>during the ILD/PH work-up. </p><br>