Evaluation of Lung Doppler Signals in Pulmonary Hypertension
Recruitment status was: Recruiting
|Official Title:||Evaluation of Lung Doppler Signals in Pulmonary Hypertension|
- Find specific features that characterize lung signals of PHTN patients in comparison to control patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]The outcomes will be elaborate by statistical analysis of whole group data
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)
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.
Two study arms:
- Prospective arm to measure LDS during right heart catheterization in patients undergoing the procedure for evaluation of PHTN.
- 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.
- Patients suspected of PHTN by echocardiogram, who are scheduled to undergo RHC (prospective arm)
- Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)
- 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.
- Determining LDS characteristics of PHTN patients
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839786
|Sheba Medical Center, Pulmonology department|
|Ramat Gan, Israel|
|Principal Investigator:||Issahar Ben-Dov, MD||Sheba Medical center, Pulmonary institute|