Pulmonary hypertension in sarcoidosis: optimizing the diagnostic approach

Pulmonary hypertension in sarcoidosis: optimizing the diagnostic approach - PULSAR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42180

Enrollment

400

Registered

2014-07-10

Start date

2015-07-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

high blood pressure in pulmonary arteries Pulmonary Hypertension

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results