CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy, CHASE Study
Study Details
Study Description
Brief Summary
CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy (CHASE Study)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PH Patients receiving targeted drugs treatment Patients with pulmonary hypertension receiving targeted drugs treatment |
Outcome Measures
Primary Outcome Measures
- Incidence of clinical worsening events 1 year after enrollment [1 year after enrollment]
All-cause death, Pulmonary hypertension progression associated with re-hospitalization, Progress of pulmonary hypertension disease
Secondary Outcome Measures
- Incidence of all-cause death 1,3,5 year(s) after enrollment [1,3,5 year(s) after enrollment]
Incidence of all-cause death 1,3,5 year(s) after enrollment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Sign informed consent;
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Between the ages of 18 and 85; ③ 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; ②Patients with malignant tumor and other diseases and life expectancy of less than half a year; ③Short-term (less than 2 weeks) patients taking targeted drugs for pulmonary hypertension
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chinese Pulmonary Vascular Disease Research Group
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHASE