NCT02426203

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

April 21, 2015

Last Update Submit

April 27, 2015

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Right ventricular ejection fraction

    3-dimensional acquisition of right ventricular ejection fraction using echocardiography

    6 months

Secondary Outcomes (5)

  • Tricuspid annular plane systolic excursion

    6 months

  • Right ventricular fractional area change

    6 months

  • Right ventricular strain

    6 months

  • Pulmonary artery acceleration time

    6 months

  • Left ventricular ejection fraction

    6 months

Study Arms (1)

Pulmonary Endarterectomy patients

Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital

Procedure: Pulmonary endarterectomy

Interventions

Pulmonary endarterectomyPROCEDURE

Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.

Also known as: Transoesophageal Echocardiography, Transthoracic Echocardiography
Pulmonary Endarterectomy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery

You may qualify if:

  • Adult patients
  • undergoing pulmonary endarterectomy surgery at Papworth Hospital
  • Willing to provide informed consent

You may not qualify if:

  • Patient refusal
  • Contraindication to transoesophageal echocardiography
  • Technical difficulty preventing adequate echocardiographic assessment of right heart function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Andrew J Roscoe, FRCA

    Papworth Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James E Moore, FANZCA FCICM

CONTACT

44 1480 830 541james.moore10@nhs.net

Andrew A Klein, FRCA FFICM

CONTACT

44 1480 830 541andrew.klein@nhs.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

April 28, 2015

Record last verified: 2015-04