Chronic Thromboembolic Pulmonary HypertensionNCT02565030
Chronic Thrombo-embolic Pulmonary Hypertension: Classification and Long Term Outcome
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Idiopathic Pulmonary Arterial Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will help to provide more up to date prognostic data on the natural history of untreated proximal CTEPH which will be helpful in discussions regarding surgical versus medical treatment and by exploring the similarities and differences between distal CTEPH and IPAH the investigators hope to get insights into… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, Idiopathic Pulmonary Arterial Hypertension
- How many people
- 1,200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Oct 2021
- 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 referred to Sheffield Pulmonary Vascular Disease Unit from the Midlands , North of England \& Wales.
Who may be able to join
- All patients with the diagnosis of chronic thromboembolic pulmonary hypertension and Idiopathic pulmonary arterial hypertension (as per the European Society of Cardiology guidelines) who presented to Sheffield Pulmonary Vascular Disease Unit at the Royal Hallamshire Hospital between 1st Jan 2001 and 1st Dec 2014.
Who cannot join
- Patients with Pulmonary Hypertension who have other causes of pulmonary hypertension in addition to chronic thromboembolic pulmonary hypertension and Idiopathic pulmonary arterial hypertension.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
This study will help to provide more up to date prognostic data on the natural history of untreated proximal CTEPH which will be helpful in discussions regarding surgical versus medical treatment and by exploring the similarities and differences between distal CTEPH and IPAH the investigators hope to get insights into disease mechanisms in patients with distal CTEPH.
Read the detailed description
Chronic thrombo-embolic pulmonary hypertension (CTEPH) is thought to represent the consequence of failure of thrombus resolution after the establishment of thrombosis within the elastic pulmonary arteries. Thrombotic material becomes fibrosed, with occlusive vascular remodeling and the development of a secondary small vessel arteriopathy, termed the two-compartment model. This results in an increase in pressure and vascular resistance in the pulmonary vasculature and leads eventually to right heart failure.
It has been demonstrated that 2 year survival for CTEPH patients with mean pulmonary arterial pressure(mPAP) >50 mm Hg was only 20%, however, preliminary data from Sheffield Teaching Hospitals suggest that survival is significantly better than this. Until recently surgery was the only treatment for CTEPH in selected patients. Studies have shown the 10 year survival in patients with CTEPH after PEA surgery was 74%. More recently, for patients with inoperable CTEPH, drug therapy has been shown to improve exercise capacity. Despite recent publications the natural history and mechanisms underlying CTEPH are poorly understood.
The main area of research focus in this study will be improving understanding of the natural history of chronic thromboembolic pulmonary hypertension. The purpose of this research protocol is to conduct a retrospective review of patients with CTEPH diagnosed at the Sheffield Centre between 2001 and 2014 to understand more about the natural history of disease including prognostic indicators. The Sheffield Service has one of the largest cohorts of CTEPH in the world (>650 diagnosed cases since 2001). Approximately half of these patients undergo curative surgery with pulmonary endarterectomy. However, a significant proportion of patients with operable disease decline surgery and a significant proportion of patients have disease that is too distal for surgery, so called distal CTEPH. There is a relative paucity of data on i) the natural history of this disease, ii) an understanding of the relative contribution of obstruction and distal vasculopathy to elevations in pulmonary vascular resistance iii) the effects of distal CTEPH on right ventricular function and iv) how distal CTEPH differs from idiopathic pulmonary arterial hypertension (IPAH).
The second part of this study will focus on understanding disease mechanisms utilising MR imaging techniques and using the Sheffield PH Biobank resource to understand differences in the IPAH and distal CTEPH cohorts. The Sheffield PH Biobank has samples and detailed phenotypic data on over 400 treatment naïve patients with all forms of pulmonary hypertension with serial sampling and long term follow up providing a unique resource to make detailed comparisons across all forms of pulmonary hypertension.
- Keywords
- Chronic thromboembolic Pulmonary Hypertension, Distal Chronic thromboembolic Pulmonary Hypertension, Proximal Chronic thromboembolic Pulmonary Hypertension, Operable disease, In-operable disease, Pulmonary Endarterectomy, PH specific targeted therapy, Phosphodiesterase type 5 Inhibitors, Endothelin Receptor Antagonist, Prostacyclin analogues, Soluble Guanylate cyclase stimulator, Sildenafil, Tadalafil, Bosentan, Ambrisentan, Macitentan, Iloprost, Riociguat, Idiopathic Pulmonary Arterial Hypertension
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CTEPH surgical disease, operated | Patients with proximal CTEPH who have undergone Pulmonary Endarterectomy (PEA) surgery | |
| CTEPH surgical disease, not operated | Patients with proximal CTEPH with operable distribution of disease\& have not undergone PEA surgery due to the following reasons: 1. Multiple co-morbidities 2. Patients choice 3. Mild disease /symptoms 4. Awaiting Surgery | |
| CTEPH non surgical | Patients with distal CTEPH with inoperable distribution of disease inaccessable to surgery. | |
| IPAH | Patients with IPAH as per European Society of Cardiology(ESC) criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All patients with CTEPH or IPAH who have been documented as having died between 01/01/2001 and 01/09/2015
Measured: Upto 176 months
Secondary outcomes (6)
Mean Pulmonary Arterial Pressure(mm of Hg)
Measure of the final Mean Pulmonary Arterial Pressure with Right Heart Catheter studies in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
Measured: Upto 176 months
Diffusion across the lung of Carbon Monoxide(mmol/min/KPa)
Measure of final Diffusion across the lung of Carbon Monoxide in patients with CTEPH \& IPAH reported between 01/01/2001 and of 01/09/2015
Measured: Upto 176 months
Emphasis 10 Quality Of Life Questionaire Score(0-50)
Measure of the Emphasis 10 Quality of Life Questionaire Score in patients with CTEPH and IPAH in their final clinic visit reported between 01/01/2001 and 01/09//2015
Measured: Upto 176 months
Incremental Shuttle Walk Distance( in metres)
The measure of the final Incremental Shuttle Walk Distance of patients with CTEPH and IPAH reported between 01/01/2015 and 01/09/2015
Measured: Upto 176 months
World Health Organization Functional Class(I-IV)
Measure of the final World Health Organization Functional Class in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
Measured: Upto 176 months
Right Ventricular Ejection Fraction(%)
Measure of the final Right Ventricular Ejection Fraction with Cardiac Magnetic Resonance Imaging(MRI) in patients with CTEPH and IPAH reported between 01/01/2001 and 01/09/2015
Measured: Upto 176 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Syed Quadery, MBBS, Principal investigator, Sheffield Teaching Hospitals NHS Foundation TrustDavid Kiely, MD, Study chair, Sheffield Teaching Hospitals NHS Foundation TrustWild Jim, PhD, Study director, University Of Sheffield, School of MedicineAndy Swift, MD, Study director, University Of Sheffield , School Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565030
- Sponsor's protocol ID
- STH18804
- Status last verified
- Jun 2022
- First submitted
- 28 Sep 2015
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Riedel M, Stanek V, Widimsky J, Prerovsky I. Longterm follow-up of patients with pulmonary thromboembolism. Late prognosis and evolution of hemodynamic and respiratory data. Chest. 1982 Feb;81(2):151-8. doi: 10.1378/chest.81.2.151.
PubMed 7056079J Cannon, K Page, M Roots, A Ponnaberanam, C Tracy, D Taboada Buasso, K Sheares, C Ng, J Dunning, S Tsui, J Pepke-Zaba, D Jenkins.Outcome after Pulmonary Endarterectomy(PEA):Long term followup of UK National Cohort. Thorax 2013;68(Suppl 3):A25-A26.
Hurdman J, Condliffe R, Elliot CA, Davies C, Hill C, Wild JM, Capener D, Sephton P, Hamilton N, Armstrong IJ, Billings C, Lawrie A, Sabroe I, Akil M, O'Toole L, Kiely DG. ASPIRE registry: assessing the Spectrum of Pulmonary hypertension Identified at a REferral centre. Eur Respir J. 2012 Apr;39(4):945-55. doi: 10.1183/09031936.00078411. Epub 2011 Sep 1.
PubMed 21885399Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
PubMed 21969018Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Goldsmith K, Coghlan JG, Pepke-Zaba J. Prognostic and aetiological factors in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2009 Feb;33(2):332-8. doi: 10.1183/09031936.00092008. Epub 2008 Oct 1.
PubMed 18829679Shahin Y, Alabed S, Alkhanfar D, Tschirren J, Rothman AMK, Condliffe R, Wild JM, Kiely DG, Swift AJ. Quantitative CT Evaluation of Small Pulmonary Vessels Has Functional and Prognostic Value in Pulmonary Hypertension. Radiology. 2022 Nov;305(2):431-440. doi: 10.1148/radiol.210482. Epub 2022 Jul 12.
PubMed 35819325Quadery SR, Swift AJ, Billings CG, Thompson AAR, Elliot CA, Hurdman J, Charalampopoulos A, Sabroe I, Armstrong IJ, Hamilton N, Sephton P, Garrad S, Pepke-Zaba J, Jenkins DP, Screaton N, Rothman AM, Lawrie A, Cleveland T, Thomas S, Rajaram S, Hill C, Davies C, Johns CS, Wild JM, Condliffe R, Kiely DG. The impact of patient choice on survival in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2018 Sep 16;52(3):1800589. doi: 10.1183/13993003.00589-2018. Print 2018 Sep.
PubMed 30002102
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Thrombo-embolic Pulmonary Hypertension: Classification and Long Term Outcome
- ClinicalTrials.gov ID
- NCT02565030
- Acronym / sponsor ID
- STH18804
- Keywords
- Chronic thromboembolic Pulmonary Hypertension, Distal Chronic thromboembolic Pulmonary Hypertension, Proximal Chronic thromboembolic Pulmonary Hypertension, Operable disease, In-operable disease, Pulmonary Endarterectomy, PH specific targeted therapy, Phosphodiesterase type 5 Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 1 Oct 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.
This study will help to provide more up to date prognostic data on the natural history of untreated proximal CTEPH which will be helpful in discussions regarding surgical versus medical treatment and by exploring the similarities and differences between distal CTEPH and IPAH the investigators hope to get insights into disease mechanisms in patients with distal CTEPH.
Detailed description
Chronic thrombo-embolic pulmonary hypertension (CTEPH) is thought to represent the consequence of failure of thrombus resolution after the establishment of thrombosis within the elastic pulmonary arteries. Thrombotic material becomes fibrosed, with occlusive vascular remodeling and the development of a secondary small vessel arteriopathy, termed the two-compartment model. This results in an increase in pressure and vascular resistance in the pulmonary vasculature and leads eventually to right heart failure.
It has been demonstrated that 2 year survival for CTEPH patients with mean pulmonary arterial pressure(mPAP) >50 mm Hg was only 20%, however, preliminary data from Sheffield Teaching Hospitals suggest that survival is significantly better than this. Until recently surgery was the only treatment for CTEPH in selected patients. Studies have shown the 10 year survival in patients with CTEPH after PEA surgery was 74%. More recently, for patients with inoperable CTEPH, drug therapy has been shown to improve exercise capacity. Despite recent publications the natural history and mechanisms underlying CTEPH are poorly understood.
The main area of research focus in this study will be improving understanding of the natural history of chronic thromboembolic pulmonary hypertension. The purpose of this research protocol is to conduct a retrospective review of patients with CTEPH diagnosed at the Sheffield Centre between 2001 and 2014 to understand more about the natural history of disease including prognostic indicators. The Sheffield Service has one of the largest cohorts of CTEPH in the world (>650 diagnosed cases since 2001). Approximately half of these patients undergo curative surgery with pulmonary endarterectomy. However, a significant proportion of patients with operable disease decline surgery and a significant proportion of patients have disease that is too distal for surgery, so called distal CTEPH. There is a relative paucity of data on i) the natural history of this disease, ii) an understanding of the relative contribution of obstruction and distal vasculopathy to elevations in pulmonary vascular resistance iii) the effects of distal CTEPH on right ventricular function and iv) how distal CTEPH differs from idiopathic pulmonary arterial hypertension (IPAH).
The second part of this study will focus on understanding disease mechanisms utilising MR imaging techniques and using the Sheffield PH Biobank resource to understand differences in the IPAH and distal CTEPH cohorts. The Sheffield PH Biobank has samples and detailed phenotypic data on over 400 treatment naïve patients with all forms of pulmonary hypertension with serial sampling and long term follow up providing a unique resource to make detailed comparisons across all forms of pulmonary hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CTEPH surgical disease, operated | – | –Patients with proximal CTEPH who have undergone Pulmonary Endarterectomy (PEA) surgery |
| CTEPH surgical disease, not operated | – | –Patients with proximal CTEPH with operable distribution of disease\& have not undergone PEA surgery due to the following reasons: 1. Multiple co-morbidities 2. Patients choice 3. Mild disease /symptoms 4. Awaiting Surgery |
| CTEPH non surgical | – | –Patients with distal CTEPH with inoperable distribution of disease inaccessable to surgery. |
| IPAH | – | –Patients with IPAH as per European Society of Cardiology(ESC) criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Sheffield Pulmonary Vascular Disease Unit from the Midlands , North of England \& Wales.
Key inclusion criteria (1 listed)
- All patients with the diagnosis of chronic thromboembolic pulmonary hypertension and Idiopathic pulmonary arterial hypertension (as per the European Society of Cardiology guidelines) who presented to Sheffield Pulmonary Vascular Disease Unit at the Royal Hallamshire Hospital between 1st Jan 2001 and 1st Dec 2014.
Key exclusion criteria (1 listed)
- Patients with Pulmonary Hypertension who have other causes of pulmonary hypertension in addition to chronic thromboembolic pulmonary hypertension and Idiopathic pulmonary arterial hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: Upto 176 months
All patients with CTEPH or IPAH who have been documented as having died between 01/01/2001 and 01/09/2015
6 secondary outcomes
Mean Pulmonary Arterial Pressure(mm of Hg)
Time frame: Upto 176 months
Diffusion across the lung of Carbon Monoxide(mmol/min/KPa)
Time frame: Upto 176 months
Emphasis 10 Quality Of Life Questionaire Score(0-50)
Time frame: Upto 176 months
Incremental Shuttle Walk Distance( in metres)
Time frame: Upto 176 months
World Health Organization Functional Class(I-IV)
Time frame: Upto 176 months
Right Ventricular Ejection Fraction(%)
Time frame: Upto 176 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Results publication: PubMed 7056079Riedel M, Stanek V, Widimsky J, Prerovsky I. Longterm follow-up of patients with pulmonary thromboembolism. Late prognosis and evolution of hemodynamic and respiratory data. Chest. 1982 Feb;81(2):151-8. doi: 10.1378/chest.81.2.151.
- Results publicationJ Cannon, K Page, M Roots, A Ponnaberanam, C Tracy, D Taboada Buasso, K Sheares, C Ng, J Dunning, S Tsui, J Pepke-Zaba, D Jenkins.Outcome after Pulmonary Endarterectomy(PEA):Long term followup of UK National Cohort. Thorax 2013;68(Suppl 3):A25-A26.
- Results publication: PubMed 21885399Hurdman J, Condliffe R, Elliot CA, Davies C, Hill C, Wild JM, Capener D, Sephton P, Hamilton N, Armstrong IJ, Billings C, Lawrie A, Sabroe I, Akil M, O'Toole L, Kiely DG. ASPIRE registry: assessing the Spectrum of Pulmonary hypertension Identified at a REferral centre. Eur Respir J. 2012 Apr;39(4):945-55. doi: 10.1183/09031936.00078411. Epub 2011 Sep 1.
- Results publication: PubMed 21969018Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
- Results publication: PubMed 18829679Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Goldsmith K, Coghlan JG, Pepke-Zaba J. Prognostic and aetiological factors in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2009 Feb;33(2):332-8. doi: 10.1183/09031936.00092008. Epub 2008 Oct 1.
- Derived from this study: PubMed 35819325Shahin Y, Alabed S, Alkhanfar D, Tschirren J, Rothman AMK, Condliffe R, Wild JM, Kiely DG, Swift AJ. Quantitative CT Evaluation of Small Pulmonary Vessels Has Functional and Prognostic Value in Pulmonary Hypertension. Radiology. 2022 Nov;305(2):431-440. doi: 10.1148/radiol.210482. Epub 2022 Jul 12.
- Derived from this study: PubMed 30002102Quadery SR, Swift AJ, Billings CG, Thompson AAR, Elliot CA, Hurdman J, Charalampopoulos A, Sabroe I, Armstrong IJ, Hamilton N, Sephton P, Garrad S, Pepke-Zaba J, Jenkins DP, Screaton N, Rothman AM, Lawrie A, Cleveland T, Thomas S, Rajaram S, Hill C, Davies C, Johns CS, Wild JM, Condliffe R, Kiely DG. The impact of patient choice on survival in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2018 Sep 16;52(3):1800589. doi: 10.1183/13993003.00589-2018. Print 2018 Sep.
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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.
Syed Quadery, MBBS principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
David Kiely, MD study chair
Sheffield Teaching Hospitals NHS Foundation Trust
Wild Jim, PhD study director
University Of Sheffield, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Idiopathic Pulmonary Arterial Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Upto 176 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565030, which also lists 7 linked publications.
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 24 Jun 2022.