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Chronic Thromboembolic Pulmonary HypertensionPEACTNCT03795740

Pulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT

A study testing 3-D CT scanning in people with Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Embolism, run by Sheng Liu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 85 years
What is being tested?
3-D CT scanning
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteChina
Study dates
1 Feb 2017to 31 Dec 2022
Phase
Interventional
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 Up to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Sheng Liu, MD contact

13501331366

liusheng@fuwai.com

Jiade Zhu, MD contact

86-15801204824

15801204824@163.com

China1 site, 1 recruiting

  • Fuwai Hospital,Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100044

    Sheng Liu, MD, 86-13501331366, liusheng@fuwai.com

    Recruiting

Other trials in China

About this study

Official title: The Precise Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension: Pulmonary Endarterectomy Guided by Three-dimensional Pulmonary Angiography

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.

Being tested
3-D CT scanning
Keywords
computed tomography, chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy, result, randomized controlled trial
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-D CT scanningDiagnostic test

    For patients in Group 1,precisely analyzed CT scanning and/or pulmonary angiography will be done,and the patients in Group 1 will receive PEA procedure with the guide of precise 3-D imaging techniques

Study groups in NCT03795740
Study groupRoleWhat they receive
PreciseExperimentalprecise PEA therapy with the guide of 3-D imaging techniques
Receives: Diagnostic Test: 3-D CT scanning
PlaceboPlacebo comparatortraditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method
Receives: Diagnostic Test: 3-D CT scanning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline pulmonary systolic pressure within 1 month

    Systolic pulmonary pressure result tested by right-sided heart

    Measured: within 1 month before and after pulmonary endarterectomy surgery

  2. Change from Baseline pulmonary mean pressure within 1 month

    Mean pulmonary pressure result tested by right-sided heart

    Measured: within 1 month before and after pulmonary endarterectomy surgery

  3. Change from Baseline pulmonary vascular resistance within 1 month

    Pulmonary vascular resistance result tested by right-sided heart

    Measured: within 1 month before and after pulmonary endarterectomy surgery

  4. Change from Baseline cardiac output within 1 month

    Cardiac output result tested by right-sided heart

    Measured: within 1 month before and after pulmonary endarterectomy surgery

  5. mortality rate after surgery

    mortality rate after surgery

    Measured: immediately after the surgery to the longest 48 months follow-up period

Secondary outcomes (8)

  1. Follow-up right ventricular ejection fraction

    Assessed by UCG

    Measured: 3-24 months after the surgeries

  2. Follow-up tricuspid annular plane systolic excursion

    Assessed by UCG

    Measured: 3-24 months after the surgeries

  3. Follow-up right ventricular anterior-posterior diameter

    Assessed by UCG

    Measured: 3-24 months after the surgeries

  4. Follow-up tricuspid insufficiency level

    Assessed by UCG

    Measured: 3-24 months after the surgeries

  5. Follow-up peak oxygen consumption (Peak O2) result

    Assessed by cardio-pulmonary exercise test (CPET)

    Measured: 6-24 months after the surgeries

  6. Follow-up Peak O2%

    Assessed by CPET

    Measured: 6-24 months after the surgeries

  7. Follow-up 6-minutes walking distance

    Assessed by CPET

    Measured: 6-24 months after the surgeries

  8. follow-up NYHA classes

    NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up

    Measured: 6-24 months after surgeries

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start1 Feb 2017
  3. Primary completion31 May 2020 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795740
Sponsor's protocol ID
liusheng-1999
Acronym
PEACT
Status last verified
Dec 2018
First submitted
19 Dec 2018
Last updated
8 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We have yet no plan to share IPD with other researchers

Publications

  • 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.

    PubMed 14602267

  • 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.

    PubMed 15163775

  • Coquoz N, Weilenmann D, Stolz D, Popov V, Azzola A, Fellrath JM, Stricker H, Pagnamenta A, Ott S, Ulrich S, Gyorik S, Pasquier J, Aubert JD. Multicentre observational screening survey for the detection of CTEPH following pulmonary embolism. Eur Respir J. 2018 Apr 4;51(4):1702505. doi: 10.1183/13993003.02505-2017. Print 2018 Apr.

    PubMed 29563171

  • Kirson NY, Birnbaum HG, Ivanova JI, Waldman T, Joish V, Williamson T. Prevalence of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in the United States. Curr Med Res Opin. 2011 Sep;27(9):1763-8. doi: 10.1185/03007995.2011.604310. Epub 2011 Jul 27.

    PubMed 21793646

  • 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.

    PubMed 26826181

  • 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.

    PubMed 24728482

  • 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.

    PubMed 21969018

Questions about this trial

What is this clinical trial studying?

A study testing 3-D CT scanning in people with Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Embolism, run by Sheng Liu at 1 site in China.

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 2 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: status not confirmed, as of the sponsor's last update on 8 Jan 2019. 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 China. 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. Some participants in this study may receive a placebo. 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 Sheng Liu, MD (13501331366, liusheng@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline pulmonary systolic pressure within 1 month (time frame: within 1 month before and after pulmonary endarterectomy surgery). The study lists 5 primary outcomes in all. 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 NCT03795740, 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 8 Jan 2019.

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