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

• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Procedure: Pulmonary endarterectomy

• Registration Number: NCT02426203
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28
• Study Start: 2015-05
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary Endarterectomy patients	Pulmonary endarterectomy	Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital

Primary Outcome Measures

Name	Time	Method
Right ventricular ejection fraction	6 months	3-dimensional acquisition of right ventricular ejection fraction using echocardiography

Secondary Outcome Measures

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