CHASE Registry of Patients With Pulmonary Hypertension Receiving Targeted Therapy

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135909
• Other study ID #: CHASE
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

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