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

NCT05311072 | Recruiting DMC

• 1 other identifier: Change-CTEPH
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Chronic Thromboembolic Pulmonary Hypertension; epidemiology; diagnosis; treatment; prognosis; balloon pulmonary angioplasty; pulmonary endarterectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• lung or heart and lung transplantation

  3 years

• changes of health related quality of life

  3 years

Other Outcomes (3)

• bleeding

  up to 3 years

• symptomatic recurrence of DVT or PE

  up to 3 years

• complication of treatment interventions (PEA or BPA)

  up to 3 years

Study Arms (3)

PEA cohort

patients with CTEPH receiving PEA

Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty

BPA cohort

patients with CTEPH receiving BPA

Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty

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

Interventions

pulmonary endarterectomy or balloon pulmonary angioplasty PROCEDURE

A multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.

Also known as: PEA or BPA

BPA cohort; PEA cohort; Pulmonary arterial hypertension (PAH)-specific medication

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients dianosed with CTEPH according to the contemporary guidelines

You may qualify if:

• Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
• Patients must be willing to provide informed consent
• 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.

You may not qualify if:

• Main cause of PH other than CTEPH
• Participation in a therapeutic clinical trial with an unknown drug;
• Withdrawal or lack of informed consent.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Frendship hospital

Beijing, 100029, China

RECRUITING

Related Publications (1)

• Zhang S, Li Y, Yang Y, Gong S, Yang Z, Hong C, Cui X, Wan J, Ji Y, Chen H, Zhu L, Li C, Cheng Z, Zhang Y, Wang Q, Luo Q, Guo L, Ma G, Han B, Liu Z, Xiong C, Wang L, Ji Q, Li F, Wang S, Zhang Z, Zhang Y, Wang D, Gao Q, Huang Q, Xie W, Zhai Z, Wang C. The management pattern and outcomes of chronic thromboembolic pulmonary hypertension: rationale and design for a Chinese real-world study. BMC Pulm Med. 2024 Jun 3;24(1):265. doi: 10.1186/s12890-024-03042-5.

  PMID: 38825688 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and PEA specimens of patients with CTEPH

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhenguo Zhai, Ph.D.

CONTACT

+86 10 84206269; zhaizhenguo2011@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 5, 2022
• Study Start: October 1, 2015
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)