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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Zhenguo Zhai, Ph.D.; Phone Number: +86 10 84206269; Email: zhaizhenguo2011@126.com

Study Locations

• China
  • Beijing, China, 100029
    • Recruiting
    • China-Japan Frendship hospital
    • Contact: Zhenguo Zhai, Ph D; Phone Number: +86 10 84206269; Email: zhaizhenguo2011@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients dianosed with CTEPH according to the contemporary guidelines

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEA cohort; patients with CTEPH receiving PEA	Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty; A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.; Other Names: PEA or BPA
BPA cohort; patients with CTEPH receiving BPA	Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty; A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.; Other Names: PEA or BPA
Pulmonary arterial hypertension (PAH)-specific medication; CTEPH patients without PEA or BPA, treatment with any PAH-specific medication, i.e. endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, drugs acting on the prostanoid pathway and prostaglandin I2 receptor agonists	Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty; A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.; Other Names: PEA or BPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	all-cause death	3 years
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
changes of health related quality of life	change of quality of life measured with the EQ-5D-5L or EmPHasis-10	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding	fatal bleeding, major bleeding, clinically relevant non-major bleeding, based on the ISTH definition	up to 3 years
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
complication of treatment interventions (PEA or BPA)	complications include lung injury, haemoptysis, residual pulmonary hypertension, etc.	up to 3 years

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 27, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: treatment; prognosis; epidemiology; diagnosis; Chronic Thromboembolic Pulmonary Hypertension; balloon pulmonary angioplasty; pulmonary endarterectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: Change-CTEPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No