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

Recruiting

• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty

• Registration Number: NCT05311072
• Lead Sponsor: China-Japan Friendship Hospital

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.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-27
• Study First Posted: 2022-04-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-20
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-02-28
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEA cohort	pulmonary endarterectomy or balloon pulmonary angioplasty	patients with CTEPH receiving PEA
BPA cohort	pulmonary endarterectomy or balloon pulmonary angioplasty	patients with CTEPH receiving BPA
Pulmonary arterial hypertension (PAH)-specific medication	pulmonary endarterectomy or balloon pulmonary angioplasty	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

Primary Outcome Measures

Name	Time	Method
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.
death	3 years	all-cause death
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.

Secondary Outcome Measures

Name	Time	Method
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
changes of health related quality of life	3 years	change of quality of life measured with the EQ-5D-5L or EmPHasis-10

Trial Locations

Locations (1)

China-Japan Frendship hospital; 🇨🇳 Beijing, China