Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311072
• Other study ID #: Change-CTEPH
• Status: Recruiting
• Start date: October 1, 2015
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: China-Japan Friendship Hospital
• Contact: Zhenguo Zhai, Ph.D.
• Phone: +86 10 84206269
• Email: zhaizhenguo2011[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2027
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Procedure:
• pulmonary endarterectomy or balloon pulmonary angioplasty
A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.

Locations

Country	Name	City	State
China	China-Japan Frendship hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bleeding	fatal bleeding, major bleeding, clinically relevant non-major bleeding, based on the ISTH definition	up to 3 years
Other	symptomatic recurrence of DVT or PE	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	up to 3 years
Other	complication of treatment interventions (PEA or BPA)	complications include lung injury, haemoptysis, residual pulmonary hypertension, etc.	up to 3 years
Primary	death	all-cause death	3 years
Primary	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).	mPAP, PVR, CO, and CI constitute critical parameters in hemodynamic assessments.	3 years
Primary	The change in 6-minute walk distance in meter, in BNP or NT-proBNP in picograms per milliliter(pg/ml), or WHO-functional class.	The 6-minute walk distance, BNP or NT-proBNP levels, and WHO-functional class are parameters used in the evaluation of functional capacity.	3 years
Secondary	lung or heart and lung transplantation	proportion of patients experiencing lung or heart and lung transplantation due to severe right heart failure during the study	3 years
Secondary	changes of health related quality of life	change of quality of life measured with the EQ-5D-5L or EmPHasis-10	3 years