Clinical trial NCT03795740: Pulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT
Official title: The Precise Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension: Pulmonary Endarterectomy Guided by Three-dimensional Pulmonary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Embolism
Keywords: computed tomography
chronic thromboembolic pulmonary hypertension
pulmonary endarterectomy
result
randomized controlled trial
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 72
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a effectiveness study of the application of high-definition enhanced computed-tomography for patients with chronic thromboembolic pulmonary hypertension(CTEPH).The patients with CTEPH was randomized into 2 groups,precise pulmonary endarterectomy group(guided by enhanced CT scanning) and traditional pulmonary endarterectomy group,the hemodynamic changes tested with right sided heart catherization from baseline to post-operative period and end-point including peri-operative deaths,follow-up mortality,follow-up parameters of ultrasonic cardiogram(UCG),right-sided heart catherization(RHC),nuclear magnetic resonance imaging(MRI),cardiac pulmonary exercise test(CPET) are documented,so as to compare the prognosis between these 2 groups.


Eligibility criteria: Inclusion Criteria:

* Definite diagnosed with chronic thromboembolic pulmonary hypertension with the right-sided cathrization and pulmonary angiography;
* The computed tomography imaging implied that the location of the embolism could be reached with surgeries;

Exclusion Criteria:

* Beyond the age limit described above,or combined with other severe conditions such as severe organ dysfunction and considered contraindicated for surgical therapy by the cardiac surgeons;
* Without the consent by the patient or his/her families;
* Acute pulmonary embolism;
* Pulmonary sarcoma;
* Pulmonary arteritis;
* Combined with cardiogenic pulmonary hypertension or idiopathic pulmonary hypertension;

Primary outcomes:
measure: Change from Baseline pulmonary systolic pressure within 1 month
timeFrame: within 1 month before and after pulmonary endarterectomy surgery
measure: Change from Baseline pulmonary mean pressure within 1 month
timeFrame: within 1 month before and after pulmonary endarterectomy surgery
measure: Change from Baseline pulmonary vascular resistance within 1 month
timeFrame: within 1 month before and after pulmonary endarterectomy surgery
measure: Change from Baseline cardiac output within 1 month
timeFrame: within 1 month before and after pulmonary endarterectomy surgery
measure: mortality rate after surgery
timeFrame: immediately after the surgery to the longest 48 months follow-up period
Secondary outcomes:
measure: Follow-up right ventricular ejection fraction
timeFrame: 3-24 months after the surgeries
measure: Follow-up tricuspid annular plane systolic excursion
timeFrame: 3-24 months after the surgeries
measure: Follow-up right ventricular anterior-posterior diameter
timeFrame: 3-24 months after the surgeries
measure: Follow-up tricuspid insufficiency level
timeFrame: 3-24 months after the surgeries
measure: Follow-up peak oxygen consumption (Peak O2) result
timeFrame: 6-24 months after the surgeries
measure: Follow-up Peak O2%
timeFrame: 6-24 months after the surgeries
measure: Follow-up 6-minutes walking distance
timeFrame: 6-24 months after the surgeries
measure: follow-up NYHA classes
timeFrame: 6-24 months after surgeries
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital,Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
citation: Jamieson SW, Kapelanski DP, Sakakibara N, Manecke GR, Thistlethwaite PA, Kerr KM, Channick RN, Fedullo PF, Auger WR. Pulmonary endarterectomy: experience and lessons learned in 1,500 cases. Ann Thorac Surg. 2003 Nov;76(5):1457-62; discussion 1462-4. doi: 10.1016/s0003-4975(03)00828-2.
citation: Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004 May 27;350(22):2257-64. doi: 10.1056/NEJMoa032274.
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citation: 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.
citation: Inami T, Kataoka M, Ando M, Fukuda K, Yoshino H, Satoh T. A new era of therapeutic strategies for chronic thromboembolic pulmonary hypertension by two different interventional therapies; pulmonary endarterectomy and percutaneous transluminal pulmonary angioplasty. PLoS One. 2014 Apr 11;9(4):e94587. doi: 10.1371/journal.pone.0094587. eCollection 2014.
citation: 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.