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

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02426203
• Other study ID #: P02016
• Status: Not yet recruiting
• Phase: N/A
• First received: April 21, 2015
• Last updated: April 27, 2015
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2015
• Source: Papworth Hospital NHS Foundation Trust
• Contact: James E Moore, FANZCA FCICM
• Phone: 44 1480 830 541
• Email: james.moore10[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension, Pulmonary

Intervention

Procedure:
• Pulmonary endarterectomy
Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular ejection fraction	3-dimensional acquisition of right ventricular ejection fraction using echocardiography	6 months	No
Secondary	Tricuspid annular plane systolic excursion		6 months	No
Secondary	Right ventricular fractional area change		6 months	No
Secondary	Right ventricular strain		6 months	No
Secondary	Pulmonary artery acceleration time		6 months	No
Secondary	Left ventricular ejection fraction		6 months	No