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NCT Number: NCT05311072

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

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.

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

pulmonary endarterectomy or balloon pulmonary angioplasty

Procedure

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

Other names: PEA or BPA

Primary outcomes

  1. death

    Time frame: 3 years

    all-cause death

  2. 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).

    Time frame: 3 years

    mPAP, PVR, CO, and CI constitute critical parameters in hemodynamic assessments.

  3. The change in 6-minute walk distance in meter, in BNP or NT-proBNP in picograms per milliliter（pg/ml), or WHO-functional class.

    Time frame: 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 outcomes

  1. lung or heart and lung transplantation

    Time frame: 3 years

    proportion of patients experiencing lung or heart and lung transplantation due to severe right heart failure during the study

  2. changes of health related quality of life

    Time frame: 3 years

    change of quality of life measured with the EQ-5D-5L or EmPHasis-10

Other outcomes

  1. bleeding

    Time frame: up to 3 years

    fatal bleeding, major bleeding, clinically relevant non-major bleeding, based on the ISTH definition

  2. symptomatic recurrence of DVT or PE

    Time frame: 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

  3. complication of treatment interventions (PEA or BPA)

    Time frame: up to 3 years

    complications include lung injury, haemoptysis, residual pulmonary hypertension, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenguo Zhai, Ph.D.

CONTACT

[email protected]

+86 10 84206269

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2027
First posted
Apr 5, 2022
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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