Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorChina-Japan Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
Patients must be willing to provide informed consent
Disqualifiers
Main cause of PH other than CTEPH
Participation in a therapeutic clinical trial with an unknown drug;
Withdrawal or lack of informed consent.
Trial population
Patients dianosed with CTEPH according to the contemporary guidelines
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
pulmonary endarterectomy or balloon pulmonary angioplasty
Procedure/SurgeryA multidisciplinary team make the final treatments for patients with CTEPH depending on their disease and preferences.
Treatment groups
1,500 Participants
are divided into 3 treatment groupsGroup A: PEA cohort1 intervention
Group B: BPA cohort1 intervention
Group C: Pulmonary arterial hypertension (PAH)-specific medication1 intervention
Trial outcomes
Primary outcomes
1
death
all-cause death
Time frame
3 years2
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.
Time frame
3 years3
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.
Time frame
3 yearsSecondary outcomes
1
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
Time frame
3 years2
changes of health related quality of life
change of quality of life measured with the EQ-5D-5L or EmPHasis-10
Time frame
3 yearsOther outcomes
1
bleeding
fatal bleeding, major bleeding, clinically relevant non-major bleeding, based on the ISTH definition
Time frame
up to 3 years2
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
Time frame
up to 3 years3
complication of treatment interventions (PEA or BPA)
complications include lung injury, haemoptysis, residual pulmonary hypertension, etc.
Time frame
up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov