A Non-interventional Study to Further Characterize the Safety and Effectiveness of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China in a Real World Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- Serious adverse events (SAEs)
Study Overview
Brief Summary
This observational study will involve analysis of data collected by the National Rare Disease Registry or medical records .The study will describe outcomes only in PAH(Pulmonary arterial hypertension) patients treated with sildenafil; there will be no comparison with another treatment group.
Approximately 100 adults with PAH will be recruited in China hospitals This NIS(non-interventional study) data will be recorded by a physician in the medical records, during the patients' clinical visits, and in the electronic Case Report Forms (CRF).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years of age at study index date; (The index date (i.e., Day 1 of the study) is the date when the first sildenafil dose was actually taken, after Revatio® is approved by China authority)
- •A diagnosis of PAH with a mean pulmonary artery pressure of ≥25 mmHg and a mean pulmonary capillary wedge pressure of ≤15 mmHg by right heart catheterization;
- •Initiated sildenafil for the treatment of their PAH based on treatment suggestion from physician ;(Patients who have received sildenafil or are receiving sildenafil are eligible to participate in this study if they met the above inclusion criteria and were ready to start sildenafil (Revatio®) for treatment at screening;)
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Serious adverse events (SAEs)
Time Frame: From baseline to week24
Incidence of SAE and the type of SAE
Treatment-emergent Adverse Events (TEAEs)
Time Frame: From baseline to week24
Incidence of TEAEs and the type of TEAEs
Secondary Outcomes
- 6-MWD (6-minute walk distance)(baseline, week 12, week24)