Clinical trial NCT06135909: CHASE Registry of Patients With Pulmonary Hypertension Receiving Targeted Therapy
Official title: CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary hypertension receiving targeted therapy

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of clinical worsening events 1 year after enrollment
timeFrame: 1 year after enrollment
Secondary outcomes:
measure: Incidence of all-cause death 1,3,5 year(s) after enrollment
timeFrame: 1,3,5 year(s) after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhihong Liu, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: