Pulmonary Hypertension Clinical Trial
Official title:
Evaluation of Lung Doppler Signals in Pulmonary Hypertension
The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.
PROTOCOL SUMMARY
Title: Evaluation of lung Doppler signals (LDS) in pulmonary hypertension (PHTN) Device:
SONARA/tek transcranial Doppler (TCD) system Study Objectives: To evaluate the LDS in
patients with PHTN that undergo (prospective arm) or underwent (retrospective arm) right
heart catheterization (RHC) in order to assess whether these signals can be used in
pulmonary hypertension diagnosis and monitoring.
Study Design:
Two study arms:
1. Prospective arm to measure LDS during right heart catheterization in patients
undergoing the procedure for evaluation of PHTN.
2. Retrospective arm to measure LDS in patients in whom previous RHC confirmed the
presence of PHTN.
Recruitment target: Prospective arm: 50 patients during 18 months. Retrospective arm: 50
patients during 18 months.
Study Population:
1. Patients suspected of PHTN by echocardiogram, who are scheduled to undergo RHC
(prospective arm)
2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)
Study endpoint:
1. Comparison of pulmonary blood pressures at rest, following vasodilator medication and
following upper extremities exercise as measured by RHC and by the LDS during the
Valsalva maneuver.
2. Determining LDS characteristics of PHTN patients
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