Clinical trial NCT05546125: a Non-interventional Study of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension (PAH)
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will comprise patients with PAH (including idiopathic pulmonary arterial hypertension, PAH associated with connective tissue disease, and PAH associated with congenital heart disease patients) Patients must meet all of the inclusion criterias to be eligible for inclusion in this study

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).


Eligibility criteria: 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

Primary outcomes:
measure: Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline to week24
measure: Serious adverse events (SAEs)
timeFrame: From baseline to week24
Secondary outcomes:
measure: 6-MWD (6-minute walk distance)
timeFrame: baseline, week 12, week24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangdong
country: China
facility: Guangdong Provincial People's Hospital
state: Guangzhou
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
state: Hunan
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: Yanan Hospital of Kunming City
state: Yunnan
Study officials:
References: