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

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

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 Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension (PAH)
• Intervention / Treatment: Other: as per Physician's prescription

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
  • Guangzhou
    • Guangdong, Guangzhou, China
      • Guangdong Provincial People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jining, Shandong, China
      • Affiliated Hospital of Jining Medical College
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Yanan Hospital of Kunming City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent Adverse Events (TEAEs)	Incidence of TEAEs and the type of TEAEs	From baseline to week24
Serious adverse events (SAEs)	Incidence of SAE and the type of SAE	From baseline to week24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-MWD (6-minute walk distance)	Change in 6-minute walk distance (6-MWD)	baseline, week 12, week24

Collaborators and Investigators

• Sponsor: Pfizer Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2021
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: A1481336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No