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NCT05958901 Clinical Trial

Pulmonary Hypertension Observational Study

Pulmonary Hypertension Clinical Trial

Official title:
A Observational Study in Chinese Patients With Pulmonary Hypertension (PH)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05958901
Other study ID # Pulmonary Hypertension of GIRH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 12, 2023
Est. completion date December 30, 2027

Study information
Verified date July 2023
Source The First Affiliated Hospital of Guangzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to establish the large PH cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date December 30, 2027
Est. primary completion date December 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - PH group: When the mean pulmonary artery pressure is greater than 25mmHg at rest or greater than 30mmHg during exercise. - Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years. Exclusion Criteria: - Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc. - Serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months. - Eye surgery in the last three months. - Retinal detachment myocardial infarction in the last 3 months. - Admission to hospital for any cardiac condition in the last month. - Heart rate over 120 beats per minute. - Antibacterial chemotherapy for tuberculosis pregnant or breast feeding.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• pulmonary hypertension
The final outcome observed was a diagnosis of pulmonary hypertension.

Locations
Country Name City State
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean pulmonary arterial pressure For an adult at sea level, when the mean pulmonary arterial pressure is greater than 25 mmHg at rest or greater than 30mmHg during exercise. 12 months
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