3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy

Sponsor

Papworth Hospital NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02426203

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy, dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although only carried out in a single UK centre, provides an excellent model for assessing right ventricular function. Right heart function is most commonly assessed using echocardiography, either transthoracic pre- and post-operatively, or transoesophageal intra-operatively. Measurement of tricuspid annular plane systolic excursion is the best validated and most commonly performed measurement for right heart function, however it may be inaccurate after sternotomy and pericardial opening, making accurate assessment difficult immediately after surgery. Therefore, we aim to compare established methods of assessing right heart function with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel reconstruction mechanism. Right ventricular function will be assessed in 51 patients who undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened, following the surgical procedure, using transoesophageal echocardiography, and at six-month outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using both modalities. This comparison should allow the investigators to determine whether such a method could replace current measurement parameters for assessment of right ventricular function, which is important for clinical management of patients in a variety of settings.

Condition or Disease	Intervention/Treatment	Phase
Chronic Thromboembolic Pulmonary Hypertension	Procedure: Pulmonary endarterectomy

Study Design

Study Type:

Observational

Anticipated Enrollment :

51 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Pulmonary Endarterectomy patients Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital	Procedure: Pulmonary endarterectomy Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery. Other Names: Transoesophageal Echocardiography Transthoracic Echocardiography

Arm

Intervention/Treatment

Pulmonary Endarterectomy patients

Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital

Procedure: Pulmonary endarterectomy

Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.

Other Names:

Transoesophageal Echocardiography

Transthoracic Echocardiography

Outcome Measures

Primary Outcome Measures

Right ventricular ejection fraction [6 months]
3-dimensional acquisition of right ventricular ejection fraction using echocardiography

Secondary Outcome Measures

Tricuspid annular plane systolic excursion [6 months]
Right ventricular fractional area change [6 months]
Right ventricular strain [6 months]
Pulmonary artery acceleration time [6 months]
Left ventricular ejection fraction [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients
undergoing pulmonary endarterectomy surgery at Papworth Hospital
Willing to provide informed consent

Exclusion Criteria:

Patient refusal
Contraindication to transoesophageal echocardiography
Technical difficulty preventing adequate echocardiographic assessment of right heart function

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Papworth Hospital NHS Foundation Trust

Investigators

Principal Investigator: Andrew J Roscoe, FRCA, Papworth Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Papworth Hospital NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02426203

Other Study ID Numbers:

P02016

First Posted:

Apr 24, 2015

Last Update Posted:

Apr 28, 2015

Last Verified:

Apr 1, 2015

Keywords provided by Papworth Hospital NHS Foundation Trust

Echocardiography

Additional relevant MeSH terms:

Hypertension, Pulmonary

Study Results

No Results Posted as of Apr 28, 2015