Recruiting NCT05372263
Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension. Basic parameters: 3 months — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Recruit at least 700 PH patients, follow up every 6 months based on a computerized follow-up system. Primary outcomes are adverse drug events and all-cause death.
Primary outcome measures
- Adverse drug events [Time frame: through study completion, an average of 6 months]
- All-cause Mortality [Time frame: through study completion, an average of 6 months]
Eligibility 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT05372263 · CST2020CT303