Multicenter registry of chronic thromboembolic pulmonary hypertension in Japan

Conditions

Chronic thromboembolic pulmonary hypertension

Masaki K, Hosokawa K, Funakoshi K, Taniguchi Y, Adachi S, Inami T, Yamashita J, Ogino H, Tsujino I, Hatano M, Yaoita N, Ikeda N, Shimokawahara H, Tanabe N, Kubota K, Shigeta A, Ogihara Y, Horimoto K, Dohi Y, Kawakami T, Tamura Y, Tatsumi K, Abe K, CTEPH AC Registry Study Group.

2024-07-236 citations

10.1016/j.jacasi.2024.05.007

Efficacy and safety of edoxaban in patients with chronic thromboembolic pulmonary hypertension: protocol for a multicentre, randomised, warfarin-controlled, parallel group trial - KABUKI trial

Kazuya Hosokawa, Kohtaro Abe, Junji Kishimoto, Yuko Kobayakawa, Koji Todaka et al. (15 authors)

BMJ Open2022-07-014 citations

10.1136/bmjopen-2022-061225

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must had been or be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) (i.e. prevalent and incident patients) 2. Patients must meet the following criteria for CTEPH at diagnosis: Mean pulmonary artery pressure (PAP) >= 25 mmHg and mean pulmonary artery wedged pressure <= 15 mmHg at rest. Abnormal VQ scan, pulmonary angiogram, or computed tomography (CT) pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines. The above criteria should be judged after at least 3 months of effective anticoagulation therapy. 3. Patients must be willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Principle investigator or co-investigator judged the patient inappropriate.

Design outcomes

Primary

Measure	Time frame
First occurrence of morbidity and mortality events, a composite endpoint composed of the following 1. All-cause death, and/or 2. Lung transplantation, and/or 3. CTEPH worsening-related rescue pulmonary endarterectomy, rescue balloon pulmonary angioplasty, or the start of parenteral pulmonary vasodilator, and/or 4. >= 15% reduction in 6-minute walk distance accompanied by worsening of WHO functional class First occurrence of clinically relavant bleeding, a composite endpoint composed of major bleeding and clinically relevant non-major bleeding based on ISTH 2015	—

Measure

Time frame

First occurrence of morbidity and mortality events, a composite endpoint composed of the following 1. All-cause death, and/or 2. Lung transplantation, and/or 3. CTEPH worsening-related rescue pulmonary endarterectomy, rescue balloon pulmonary angioplasty, or the start of parenteral pulmonary vasodilator, and/or 4. >= 15% reduction in 6-minute walk distance accompanied by worsening of WHO functional class First occurrence of clinically relavant bleeding, a composite endpoint composed of major bleeding and clinically relevant non-major bleeding based on ISTH 2015

—

Secondary

Measure	Time frame
First occurrence of symptomatic venous thromboembolism	—

Countries

Japan

Contacts

Public ContactKazuya Hosokawa

Kyushu University Hospital Cardiovascular Medicine

hosokawa.kazuya.712@m.kyushu-u.ac.jp092-642-5360

Outcome results