Clinical trial NCT02426203: 3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy
Official title: Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Echocardiography
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2015-04-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: Right ventricular ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: Tricuspid annular plane systolic excursion
timeFrame: 6 months
measure: Right ventricular fractional area change
timeFrame: 6 months
measure: Right ventricular strain
timeFrame: 6 months
measure: Pulmonary artery acceleration time
timeFrame: 6 months
measure: Left ventricular ejection fraction
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Andrew J Roscoe, FRCA
role: PRINCIPAL_INVESTIGATOR
References: