Chronic Thromboembolic Pulmonary Hypertension
Conditions
Keywords
Chronic Thromboembolic Pulmonary Hypertension, epidemiology, diagnosis, treatment, prognosis, balloon pulmonary angioplasty, pulmonary endarterectomy
Brief summary
The Change Database is a prospective, observational multi-center disease registry, which will collect data on patients with chronic thromboembolic pulmonary hypertension (CTEPH) in China. It aims to illustrate the epidemiology, management and long-term outcomes of CTEPH.
Detailed description
18 CTEPH centers will be enrolled in the study. The epidemiology, diagnosis，treatments (pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA) and targeted medical therapy), and long-term prognosis of CTEPH will be evaluated.
Interventions
PROCEDUREpulmonary endarterectomy or balloon pulmonary angioplasty
A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.
Sponsors
China-Japan Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) 2. Patients must be willing to provide informed consent 3. Patients must meet the following criteria for CTEPH: a mean pulmonary artery pressures (mPAP) ≥20 mmHg combined with a pulmonary vascular resistance (PVR) ≥ 3 WU and pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg documented at right heart catheterization with radiographic evidence of organized thrombi involving the pulmonary arteries after 3 months of effective anticoagulation.
Exclusion criteria
1. Main cause of PH other than CTEPH 2. Participation in a therapeutic clinical trial with an unknown drug; 3. Withdrawal or lack of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in 6-minute walk distance in meter, in BNP or NT-proBNP in picograms per milliliter（pg/ml), or WHO-functional class. | 3 years | The 6-minute walk distance, BNP or NT-proBNP levels, and WHO-functional class are parameters used in the evaluation of functional capacity. |
| death | 3 years | all-cause death |
| The change in mean pulmonary artery pressure (mPAP) in millimetre of mercury (mmHg), pulmonary vascular resistance (PVR) in Wood units, cardiac output (CO) in liter per minute (L/min) or cardiac index (CI) in liter per minute (L/min). | 3 years | mPAP, PVR, CO, and CI constitute critical parameters in hemodynamic assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of health related quality of life | 3 years | change of quality of life measured with the EQ-5D-5L or EmPHasis-10 |
| lung or heart and lung transplantation | 3 years | proportion of patients experiencing lung or heart and lung transplantation due to severe right heart failure during the study |
Other
| Measure | Time frame | Description |
|---|---|---|
| bleeding | up to 3 years | fatal bleeding, major bleeding, clinically relevant non-major bleeding, based on the ISTH definition |
| complication of treatment interventions (PEA or BPA) | up to 3 years | complications include lung injury, haemoptysis, residual pulmonary hypertension, etc. |
| symptomatic recurrence of DVT or PE | up to 3 years | reappearance of clinical manifestations or symptoms associated with DVT or PE after a previous episode or treatment, include leg pain, swelling, warmth, redness, or shortness of breath,etc |
Countries
China
Contacts
Primary ContactZhenguo Zhai, Ph.D.
Outcome results
None listed