Chronic Thromboembolic Pulmonary HypertensionGO-CTEPHNCT05110066
BPA vs. PEA in CTEPH
A study testing Pulmonary endarterectomy and Balloon pulmonary angioplasty in people with Chronic Thromboembolic Pulmonary Hypertension, run by University of Aarhus at 2 sites in 2 countries.
Trial summary
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Pulmonary endarterectomy and Balloon pulmonary angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2024to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee
- Written informed consent from the patient
- Patient age >17 and <80 years
- Able to understand and follow instructions and to participate in the entire study period
Who cannot join
- Life expectancy <12 months
- Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
- Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
- Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable*
- Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
- Previous balloon pulmonary angioplasty or pulmonary endarterectomy
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Asger Andersen, PhD
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Ppworth
Cambridge
Joanna Pepke-Zaba
About this study
Official title: Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.
Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.
Read the detailed description
An investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. The study will randomize (1:1) 152 patients with CTEPH who are eligible for both PEA and BPA. Patients will be screened for study inclusion at the local CTEPH multidisciplinary team conference and eligibility for both PEA and BPA will be confirmed by a central adjudication committee.
PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session.
Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.
- Being tested
- Pulmonary endarterectomy, Balloon pulmonary angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary endarterectomyProcedure or surgery
Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
Balloon pulmonary angioplastyProcedure or surgery
Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.
| Study group | Role | What they receive |
|---|---|---|
| BPA group | Active comparator | Balloon pulmonary angioplasty. Typically 4-8 sessions are needed to treat the patient. The specific pre-planning protocol, choice of wires and balloons, the number of vessels treated per session, and the decision that no further BPA sessions are needed is at the discretion of the treating physician. Receives: Procedure: Balloon pulmonary angioplasty |
| PEA group | Active comparator | Patients randomized to PEA will undergo surgery within 4 months after randomization and optional run-in phase. Distality of the dissection plane is at the discretion of the operating physicians. Receives: Procedure: Pulmonary endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary vascular resistance
Change in pulmonary vascular resistance from baseline to 4-months and 12-months after the procedure(s). Patients on medical treatments at baseline will remain on medical treatments until the assessment of the primary endpoint, and be taken off if hemodynamics permit
Measured: 4 months and 12 months
Secondary outcomes (7)
Mean pulmonary artery pressure
Mean pulmonary artery pressure measured by right heart catheterization
Measured: 4 months and 12 months
Cardiac index
Cardiac index measured by right heart catheterization
Measured: 4 months and 12 months
Mean right atrial pressure
Right atrial pressure measured by right heart catheterization
Measured: 4 months and 12 months
Six minutes walking distance
Six minutes walking distance
Measured: 4 months and 12 months
Time to clinical worsening
Clinical worsening includes all-cause mortality, nonelective hospitalization for pulmonary artery hypertension, and disease progression (disease progression is defined as a reduction from baseline in the six minutes walking distance by 15% plus worsening functional class (except for patients already in Orld health organization functional class IV).)
Measured: 4 months and 12 months
N-terminal pro B-type natriuretic peptide
N-terminal pro B-type natriuretic peptide
Measured: 4 months and 12 months
Quality of life evaluated by the "Living with pulmonary hypertension questionnaire"
Measured by the use of Living with pulmonary hypertension questionnaire (21 questions scored 0-5. Minimum score is 0 and maximum score is 105. Low score means high quality of life and a high score means a low quality of life).
Measured: 4 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Kerckhoff Klinik, Medical University of Vienna, Papworth Hospital NHS Foundation Trust, St. Antonius Hospital, Utrecht University, KU Leuven, Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- Irene Lang, MD,Prof, Study chair, Medical University of ViennaHarm Jan Bogaard, MD, Prof., Study chair, Amsterdam University Medical CenterMarion Delcroix, MD, Prof., Study chair, KU LeuvenMarco Post, MD, Prof., Study chair, St. Antonius HospitalGregely Meszaros, MD, Study chair, Pulmonary Hypertension Association EuropeJohanna Pepke-Zaba, MD, Prof., Study chair, Papworth Hospital NHS Foundation TrustChristoph Wiedenroth, MD, Study chair, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110066
- Sponsor's protocol ID
- 190580-0002
- Acronym
- GO-CTEPH
- Status last verified
- Apr 2024
- First submitted
- 4 Oct 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.
PubMed 22700839Gall H, Hoeper MM, Richter MJ, Cacheris W, Hinzmann B, Mayer E. An epidemiological analysis of the burden of chronic thromboembolic pulmonary hypertension in the USA, Europe and Japan. Eur Respir Rev. 2017 Mar 29;26(143):160121. doi: 10.1183/16000617.0121-2016. Print 2017 Mar 31.
PubMed 28356407Gerges C, Gerges M, Friewald R, Fesler P, Dorfmuller P, Sharma S, Karlocai K, Skoro-Sajer N, Jakowitsch J, Moser B, Taghavi S, Klepetko W, Lang IM. Microvascular Disease in Chronic Thromboembolic Pulmonary Hypertension: Hemodynamic Phenotyping and Histomorphometric Assessment. Circulation. 2020 Feb 4;141(5):376-386. doi: 10.1161/CIRCULATIONAHA.119.041515. Epub 2020 Jan 3.
PubMed 31896275Delcroix M, Vonk Noordegraaf A, Fadel E, Lang I, Simonneau G, Naeije R. Vascular and right ventricular remodelling in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2013 Jan;41(1):224-32. doi: 10.1183/09031936.00047712. Epub 2012 Aug 16.
PubMed 22903956Riedel 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 7056079Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
PubMed 26318161Jenkins D, Madani M, Fadel E, D'Armini AM, Mayer E. Pulmonary endarterectomy in the management of chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2017 Mar 15;26(143):160111. doi: 10.1183/16000617.0111-2016. Print 2017 Jan.
PubMed 28298388Pepke-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 21969018Lang I, Meyer BC, Ogo T, Matsubara H, Kurzyna M, Ghofrani HA, Mayer E, Brenot P. Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2017 Mar 29;26(143):160119. doi: 10.1183/16000617.0119-2016. Print 2017 Mar 31.
PubMed 28356406Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29.
PubMed 26826181Khan MS, Amin E, Memon MM, Yamani N, Siddiqi TJ, Khan SU, Murad MH, Mookadam F, Figueredo VM, Doukky R, Benza RL, Krasuski RA. Meta-analysis of use of balloon pulmonary angioplasty in patients with inoperable chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2019 Sep 15;291:134-139. doi: 10.1016/j.ijcard.2019.02.051. Epub 2019 Feb 23.
PubMed 30850238Tanabe N, Kawakami T, Satoh T, Matsubara H, Nakanishi N, Ogino H, Tamura Y, Tsujino I, Ogawa A, Sakao S, Nishizaki M, Ishida K, Ichimura Y, Yoshida M, Tatsumi K. Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: A systematic review. Respir Investig. 2018 Jul;56(4):332-341. doi: 10.1016/j.resinv.2018.03.004. Epub 2018 Jul 3.
PubMed 30008295Kim NH, Delcroix M, Jenkins DP, Channick R, Dartevelle P, Jansa P, Lang I, Madani MM, Ogino H, Pengo V, Mayer E. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D92-9. doi: 10.1016/j.jacc.2013.10.024.
PubMed 24355646Mayer E, Jenkins D, Lindner J, D'Armini A, Kloek J, Meyns B, Ilkjaer LB, Klepetko W, Delcroix M, Lang I, Pepke-Zaba J, Simonneau G, Dartevelle P. Surgical management and outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. J Thorac Cardiovasc Surg. 2011 Mar;141(3):702-10. doi: 10.1016/j.jtcvs.2010.11.024.
PubMed 21335128
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT05110066
- Acronym / sponsor ID
- GO-CTEPH / 190580-0002
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Kerckhoff Klinik, Medical University of Vienna, Papworth Hospital NHS Foundation Trust, St. Antonius Hospital, Utrecht University, KU Leuven, Amsterdam UMC, location VUmc
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 5 Nov 2021 (actual)
- 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 (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.
Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.
Detailed description
An investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. The study will randomize (1:1) 152 patients with CTEPH who are eligible for both PEA and BPA. Patients will be screened for study inclusion at the local CTEPH multidisciplinary team conference and eligibility for both PEA and BPA will be confirmed by a central adjudication committee.
PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session.
Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPA group | Active comparator | Procedure: Balloon pulmonary angioplastyBalloon pulmonary angioplasty. Typically 4-8 sessions are needed to treat the patient. The specific pre-planning protocol, choice of wires and balloons, the number of vessels treated per session, and the decision that no further BPA sessions are needed is at the discretion of the treating physician. |
| PEA group | Active comparator | Procedure: Pulmonary endarterectomyPatients randomized to PEA will undergo surgery within 4 months after randomization and optional run-in phase. Distality of the dissection plane is at the discretion of the operating physicians. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee
- Written informed consent from the patient
- Patient age >17 and <80 years
- Able to understand and follow instructions and to participate in the entire study period
Key exclusion criteria (6 listed)
- Life expectancy <12 months
- Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
- Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
- Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable*
- Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
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 endarterectomySurgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass. | Procedure or surgery | PEA group |
| Balloon pulmonary angioplastyPercutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons. | Procedure or surgery | BPA group |
Primary outcome
Change in pulmonary vascular resistance
Time frame: 4 months and 12 months
Change in pulmonary vascular resistance from baseline to 4-months and 12-months after the procedure(s). Patients on medical treatments at baseline will remain on medical treatments until the assessment of the primary endpoint, and be taken off if hemodynamics permit
7 secondary outcomes
Mean pulmonary artery pressure
Time frame: 4 months and 12 months
Cardiac index
Time frame: 4 months and 12 months
Mean right atrial pressure
Time frame: 4 months and 12 months
Six minutes walking distance
Time frame: 4 months and 12 months
Time to clinical worsening
Time frame: 4 months and 12 months
N-terminal pro B-type natriuretic peptide
Time frame: 4 months and 12 months
Quality of life evaluated by the "Living with pulmonary hypertension questionnaire"
Time frame: 4 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 22700839Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.
- Background: PubMed 28356407Gall H, Hoeper MM, Richter MJ, Cacheris W, Hinzmann B, Mayer E. An epidemiological analysis of the burden of chronic thromboembolic pulmonary hypertension in the USA, Europe and Japan. Eur Respir Rev. 2017 Mar 29;26(143):160121. doi: 10.1183/16000617.0121-2016. Print 2017 Mar 31.
- Background: PubMed 31896275Gerges C, Gerges M, Friewald R, Fesler P, Dorfmuller P, Sharma S, Karlocai K, Skoro-Sajer N, Jakowitsch J, Moser B, Taghavi S, Klepetko W, Lang IM. Microvascular Disease in Chronic Thromboembolic Pulmonary Hypertension: Hemodynamic Phenotyping and Histomorphometric Assessment. Circulation. 2020 Feb 4;141(5):376-386. doi: 10.1161/CIRCULATIONAHA.119.041515. Epub 2020 Jan 3.
- Background: PubMed 22903956Delcroix M, Vonk Noordegraaf A, Fadel E, Lang I, Simonneau G, Naeije R. Vascular and right ventricular remodelling in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2013 Jan;41(1):224-32. doi: 10.1183/09031936.00047712. Epub 2012 Aug 16.
- Background: 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.
- Background: PubMed 26318161Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
- Background: PubMed 28298388Jenkins D, Madani M, Fadel E, D'Armini AM, Mayer E. Pulmonary endarterectomy in the management of chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2017 Mar 15;26(143):160111. doi: 10.1183/16000617.0111-2016. Print 2017 Jan.
- Background: 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.
- Background: PubMed 28356406Lang I, Meyer BC, Ogo T, Matsubara H, Kurzyna M, Ghofrani HA, Mayer E, Brenot P. Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2017 Mar 29;26(143):160119. doi: 10.1183/16000617.0119-2016. Print 2017 Mar 31.
- Background: PubMed 26826181Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29.
- Background: PubMed 30850238Khan MS, Amin E, Memon MM, Yamani N, Siddiqi TJ, Khan SU, Murad MH, Mookadam F, Figueredo VM, Doukky R, Benza RL, Krasuski RA. Meta-analysis of use of balloon pulmonary angioplasty in patients with inoperable chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2019 Sep 15;291:134-139. doi: 10.1016/j.ijcard.2019.02.051. Epub 2019 Feb 23.
- Background: PubMed 30008295Tanabe N, Kawakami T, Satoh T, Matsubara H, Nakanishi N, Ogino H, Tamura Y, Tsujino I, Ogawa A, Sakao S, Nishizaki M, Ishida K, Ichimura Y, Yoshida M, Tatsumi K. Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: A systematic review. Respir Investig. 2018 Jul;56(4):332-341. doi: 10.1016/j.resinv.2018.03.004. Epub 2018 Jul 3.
- Individual participant dataSharing planned: Yes
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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.
Irene Lang, MD,Prof study chair
Medical University of Vienna
Harm Jan Bogaard, MD, Prof. study chair
Amsterdam University Medical Center
Marion Delcroix, MD, Prof. study chair
KU Leuven
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary endarterectomy and Balloon pulmonary angioplasty in people with Chronic Thromboembolic Pulmonary Hypertension, run by University of Aarhus at 2 sites in 2 countries.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asger Andersen, MD, ass.prof. (40138052 ext. 0045, asger.andersen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary vascular resistance (time frame: 4 months and 12 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 NCT05110066, which also lists 14 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 29 Apr 2024.