Chronic Thromboembolic Pulmonary HypertensionNCT02426203
3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Papworth Hospital NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Pulmonary endarterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery
Who may be able to join
- Adult patients
- undergoing pulmonary endarterectomy surgery at Papworth Hospital
- Willing to provide informed consent
Who cannot join
- Patient refusal
- Contraindication to transoesophageal echocardiography
- Technical difficulty preventing adequate echocardiographic assessment of right heart function
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy
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.
- Being tested
- Pulmonary endarterectomy
- Keywords
- Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary endarterectomyProcedure or surgery
Also called Transoesophageal Echocardiography, Transthoracic Echocardiography
Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Endarterectomy patients | Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital Receives: Procedure: Pulmonary endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular ejection fraction
3-dimensional acquisition of right ventricular ejection fraction using echocardiography
Measured: 6 months
Secondary outcomes (5)
Tricuspid annular plane systolic excursion
Measured: 6 months
Right ventricular fractional area change
Measured: 6 months
Right ventricular strain
Measured: 6 months
Pulmonary artery acceleration time
Measured: 6 months
Left ventricular ejection fraction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew J Roscoe, FRCA, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426203
- Sponsor's protocol ID
- P02016
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy
- ClinicalTrials.gov ID
- NCT02426203
- Acronym / sponsor ID
- P02016
- Keywords
- Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- May 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Endarterectomy patients | – | Procedure: Pulmonary endarterectomyPatients undergoing pulmonary endarterectomy surgery at Papworth Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery
Key inclusion criteria (3 listed)
- Adult patients
- undergoing pulmonary endarterectomy surgery at Papworth Hospital
- Willing to provide informed consent
Key exclusion criteria (3 listed)
- Patient refusal
- Contraindication to transoesophageal echocardiography
- Technical difficulty preventing adequate echocardiographic assessment of right heart function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary endarterectomyAlso: Transoesophageal Echocardiography, Transthoracic EchocardiographyEchocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery. | Procedure or surgery | Pulmonary Endarterectomy patients |
Primary outcome
Right ventricular ejection fraction
Time frame: 6 months
3-dimensional acquisition of right ventricular ejection fraction using echocardiography
5 secondary outcomes
Tricuspid annular plane systolic excursion
Time frame: 6 months
Right ventricular fractional area change
Time frame: 6 months
Right ventricular strain
Time frame: 6 months
Pulmonary artery acceleration time
Time frame: 6 months
Left ventricular ejection fraction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Roscoe, FRCA principal investigator
Papworth Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Papworth Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James E Moore, FANZCA FCICM (44 1480 830 541, james.moore10@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular ejection fraction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.