a Non-interventional Study of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China

Pfizer

Status: Completed

Conditions: Pulmonary Arterial Hypertension (PAH)

Treatments: Other: as per Physician's prescription

Study type: Observational

Funder types: Industry

Identifiers

NCT05546125

A1481336

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• No