Evaluation of Lung Doppler Signals in Pulmonary Hypertension

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01839786

Enrollment

Registered

2013-04-25

Start date

2013-05-31

Completion date

2017-02-28

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension, Doppler, Valsalva

Brief 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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Prospective arm: * Man or woman aged over 18. * With suspicion or diagnosis of pulmonary hypertension. * Scheduled to undergo right heart catheterization * Able and willing to give informed consent. 2. Retrospective arm: * Man or woman aged over 18. * With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past. * Able and willing to give informed consent.

Exclusion criteria

1. Both arms: * Minor (aged \< 18). * People unable or unwilling to give informed consent. * Hemodynamically unstable patients. * Pregnant women. 2. Prospective arm only: * Patients with contra-indication to right heart catheterization. * Patients incapable of performing a Valsalva maneuver. * Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma

Design outcomes

Primary

Measure	Time frame	Description
Find specific features that characterize lung signals of PHTN patients in comparison to control patients	18 months	The outcomes will be elaborate by statistical analysis of whole group data

Countries

Israel

Outcome results