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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02426203
Recruitment Status : Unknown
Verified April 2015 by Papworth Hospital NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2015
Last Update Posted : April 28, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Chronic Thromboembolic Pulmonary Hypertension Procedure: Pulmonary endarterectomy

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Study Type : Observational
Estimated 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 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Group/Cohort 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

Primary Outcome Measures :
  1. Right ventricular ejection fraction [ Time Frame: 6 months ]
    3-dimensional acquisition of right ventricular ejection fraction using echocardiography

Secondary Outcome Measures :
  1. Tricuspid annular plane systolic excursion [ Time Frame: 6 months ]
  2. Right ventricular fractional area change [ Time Frame: 6 months ]
  3. Right ventricular strain [ Time Frame: 6 months ]
  4. Pulmonary artery acceleration time [ Time Frame: 6 months ]
  5. Left ventricular ejection fraction [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02426203

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Contact: James E Moore, FANZCA FCICM 44 1480 830 541
Contact: Andrew A Klein, FRCA FFICM 44 1480 830 541

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

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Responsible Party: Papworth Hospital NHS Foundation Trust Identifier: NCT02426203    
Other Study ID Numbers: P02016
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Papworth Hospital NHS Foundation Trust:
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases