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van CCT (UK)

van CCT (UK)

Pulmonary hypertension in pulmonary sarcoidosis - optimizing the diagnostic strategy

- candidate number22433
- NTR NumberNTR5295
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jul-2015
- Secondary IDs80-84200-98-15225 ZonMW
- Public TitlePulmonary hypertension in pulmonary sarcoidosis - optimizing the diagnostic strategy
- Scientific TitlePulmonary hypertension in pulmonary sarcoidosis - optimizing the diagnostic strategy
- hypothesisFirst, 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.
- Healt Condition(s) or Problem(s) studiedPulmonary hypertension, Sarcoidosis
- 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 criteriaFor 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 26-jun-2015
- planned closingdate26-jun-2019
- Target number of participants400
- InterventionsAll 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).
- Primary outcomeNon-invasive diagnosis of pulmonary hypertension in pulmonary sarcoidosis.
- Secondary outcome1. 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.
- TimepointsThe 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.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMw. drs. Marloes P. Huitema
- CONTACT for SCIENTIFIC QUERIESMw. drs. Marloes P. Huitema
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-jul-2015 - 19-aug-2015

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