Monitoring the safety of targeted drugs for pulmonary hypertension using a computerized system
Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
This study is trying to see how safe targeted drugs are for people with pulmonary hypertension by following at least 700 patients over time using a computerized system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 3 Months to 85 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05372263 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit at least 700 patients diagnosed with various forms of pulmonary hypertension and follow them up every six months using a computerized follow-up system. The primary focus is to monitor adverse drug events and all-cause mortality among participants receiving targeted therapies. By systematically collecting and analyzing data, the study seeks to enhance understanding of the safety profiles of these medications in a real-world setting. The study will include patients aged from 3 months to 85 years who meet specific diagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates include patients aged 3 months to 85 years diagnosed with specific types of pulmonary hypertension who are receiving targeted drug therapy.
Not a fit: Patients with pulmonary hypertension related to left heart disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety monitoring of targeted therapies for pulmonary hypertension, leading to better patient outcomes.
How similar studies have performed: Other studies have shown success in monitoring drug safety in similar patient populations, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 3 months to 85 years, no sex preference; * Right heart catheter meet the following conditions simultaneously: mPAP≥25mmHg, and PVR \> 3 Wood units(in children PVRi \> 3 WU x m2), and PAWP≤15 mmHg at rest; * Patients diagnosed with group 1,2,4,5 PH according to the WHO classification, detailed description is as follows: Pulmonary arterial hypertension, Lung disease / chronic hypoxia associated pulmonary hypertension, Pulmonary hypertension associated with pulmonary artery stenosis / obstruction and Pulmonary hypertension caused by other multiple factors * Take at least one pulmonary hypertension targeted drug or calcium antagonist; * Signed written informed consent. Exclusion Criteria: * Patients diagnosed with pulmonary hypertension related to left heart disease;
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Lu Hua, M.D — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Tingting Guo, M.D
- Email: 18610094559@163.com
- Phone: +86 18610094559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.