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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02426203
Other study ID # P02016
Secondary ID
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


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
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