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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06135909
Other study ID # CHASE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2027

Study information

Verified date November 2023
Source Chinese Pulmonary Vascular Disease Research Group
Contact Zhihong Liu, M.D., Ph.D
Phone 8601088396816
Email zhihongliufuwai@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy (CHASE Study)


Description:

The purpose of this study was to establish the clinical characteristics and treatment strategies of targeted pulmonary hypertension patients in China: a multicenter, prospective case registry (CHASE) study to describe the clinical characteristics, treatment used, disease progression, and outcomes (e.g., death, hospitalization) of patients taking targeted drugs in real-world clinical practice. This study will collect high-quality real-world data that can be used as a standalone dataset or combined with other data sources to address critical issues in the PH field. This is a prospective, observational, multicenter study. The expected number of enrolled cases for the entire study: at least 5000; No experimental group and control group were divided. Patients were followed up every 6 months ±2 weeks after enrollment for 3 years. The study selected patients who signed informed consent, aged 18-25 years, clinically diagnosed with pulmonary hypertension, and were applying or planning to apply targeted drugs for pulmonary hypertension as the study objects. The primary endpoint was the incidence of clinical exacerbations at 1 year after enrollment. Secondary endpoints were all-cause mortality at 1, 2, and 3 years after enrollment, rate of lung transplantation or combined cardiopulmonary transplantation, 6-minute walking distance, NT-proBNP level, WHO cardiac function grade, ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter, pulmonary hypertension targeted drug regimen, and incidence of associated adverse reactions.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Sign informed consent; - Between the ages of 18 and 85; - Clinical diagnosis of pulmonary hypertension, using or planning to use pulmonary hypertension targeted drugs (including any one or more of the following: prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase agonists and prostacyclin receptor agonists). Exclusion Criteria: - Have a history of mental illness or drug or poison addiction, and can not sign informed consent or can not cooperate with the experimental study; - Patients with malignant tumor and other diseases and life expectancy of less than half a year; - Short-term (less than 2 weeks) patients taking targeted drugs for pulmonary hypertension

Study Design


Locations

Country Name City State
China Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of clinical worsening events 1 year after enrollment All-cause death, Pulmonary hypertension progression associated with re-hospitalization, Progress of pulmonary hypertension disease 1 year after enrollment
Secondary Incidence of all-cause death 1,3,5 year(s) after enrollment Incidence of all-cause death 1,3,5 year(s) after enrollment 1,3,5 year(s) after enrollment
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