No registrations found.
ID
Source
Brief title
Health condition
Pulmonary hypertension, pulmonary sarcoidosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Non-invasive diagnosis of pulmonary hypertension in pulmonary sarcoidosis.
Secondary outcome
1. Assessment of the etiology of pulmonary hypertension in pulmonary sarcoidosis in patients with pulmonary hypertension.
2. Development of pulmonary hypertension after 1 year follow up for patients who are initialy diagnosed as no pulmonary hypertension.
Study objective
First, non-invasive diagnostic tools can optimize the diagnostic strategy, in order to minimize the number of invasive diagnostic procedures.
Second, invasive imaging of the pulmonary artery can further differentiate the mechanisms involved in PH associated sarcoidosis.
Study design
The first timepoint is the initial diagnostic screening, including right heart catheterization and IVUS if indicated. All diagnostic procedures will be performed within weeks from each other.
The second timepoint, only for patients diagnosed as no pulmonary hypertension, is after one year of initial screening.
Intervention
All patients will be screened for the presence of pulmonary hypertension by a standardized diagnostic strategy (Local standard protocol) including history taking and physical examination, electrocardiogram and biomarkers related to pulmonary hypertension (NT-pro BNP, troponin and uric acid) and echocardiography with additional 3D-echocardiography (Ventripoint® system) in order to assess right ventricle volume and function measurements (). In a subgroup of patients with the diagnosis PH possible or likely based on the diagnostic strategy (as suggested by the international guidelines for pulmonary hypertension), right heart catheterization will be performed to measure pulmonary hemodynamics. Additionally, this will include intravascular imaging of the pulmonary artery using IVUS (Revolution® 45 MHz Rotational IVUS Imaging Catheter).
Marloes P. Huitema
Koekoekslaan 1
Nieuwegein 3534CM
The Netherlands
Tel: 030 - 609 80 99
Email: mp.huitema@antoniusziekenhuis.nl
Marloes P. Huitema
Koekoekslaan 1
Nieuwegein 3534CM
The Netherlands
Tel: 030 - 609 80 99
Email: mp.huitema@antoniusziekenhuis.nl
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 or above
Exclusion criteria
For 3D-echocardiography:
- Pacemaker or Implantable Cardioverter 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5155 |
NTR-old | NTR5295 |
Other | ZonMW : 80-84200-98-15225 |