Trials / Terminated
TerminatedNCT01839786
Evaluation of Lung Doppler Signals in Pulmonary Hypertension
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (actual)
- Sponsor
- Echosense Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2017-01-01
- Completion
- 2017-02-01
- First posted
- 2013-04-25
- Last updated
- 2017-03-21
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT01839786. Inclusion in this directory is not an endorsement.