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| Name | Class |
|---|---|
| Kerckhoff Klinik | OTHER |
| Medical University of Vienna | OTHER |
| Papworth Hospital NHS Foundation Trust | OTHER_GOV |
| St. Antonius Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary endarterectomy | Procedure | Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean pulmonary artery pressure | Mean pulmonary artery pressure measured by right heart catheterization | 4 months and 12 months |
| Cardiac index | Cardiac index measured by right heart catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative/peri-interventional complications | Complications related to balloon pulmonary angioplasty and pulmonary endarterectomy will be recorded | 30 days |
| Total length of hospital stay in both groups |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asger Andersen, MD, ass.prof. | Contact | 40138052 | 0045 | asger.andersen@clin.au.dk |
| Kristina Laut Matzen, RN,PhD | Contact | +4521673903 | krlaut@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Irene Lang, MD,Prof | Medical University of Vienna | Study Chair |
| Harm Jan Bogaard, MD, Prof. | Amsterdam University Medical Center | Study Chair |
| Marion Delcroix, MD, Prof. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22700839 | Background | 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. | |
| 28356407 | Background | Gall 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. |
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| OTHER |
| Utrecht University | OTHER |
| KU Leuven | OTHER |
| Amsterdam UMC, location VUmc | OTHER |
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| Balloon pulmonary angioplasty | Procedure | Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons. |
|
| 4 months and 12 months |
| Mean right atrial pressure | Right atrial pressure measured by right heart catheterization | 4 months and 12 months |
| Six minutes walking distance | Six minutes walking distance | 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).) | 4 months and 12 months |
| N-terminal pro B-type natriuretic peptide | N-terminal pro B-type natriuretic peptide | 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). | 4 months and 12 months |
Time of hospital stay will be recorded
| 4 month |
| Median survival at 12 month | Deaths will be recorded recorded and a median 12 month survival will be calculated. | 12 months |
| KU Leuven |
| Study Chair |
| Marco Post, MD, Prof. | St. Antonius Hospital | Study Chair |
| Gregely Meszaros, MD | Pulmonary Hypertension Association Europe | Study Chair |
| Johanna Pepke-Zaba, MD, Prof. | Papworth Hospital NHS Foundation Trust | Study Chair |
| Christoph Wiedenroth, MD | Kerckhoff Klinik | Study Chair |
| Royal Ppworth | Recruiting | Cambridge | United Kingdom |
|
| 31896275 | Background | Gerges 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. |
| 22903956 | Background | Delcroix 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. |
| 7056079 | Background | 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. |
| 26318161 | Background | Galie 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. |
| 28298388 | Background | Jenkins 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. |
| 21969018 | Background | Pepke-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. |
| 28356406 | Background | Lang 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. |
| 26826181 | Background | Delcroix 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. |
| 30850238 | Background | Khan 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. |
| 30008295 | Background | Tanabe 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. |
| 24355646 | Background | Kim 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. |
| 21335128 | Background | Mayer 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. |