Pulmonary Hypertension Observational Study

NCT05958901 | Recruiting

• 1 other identifier: Pulmonary Hypertension of GIRH
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

pulmonary hypertension

Other: pulmonary hypertension

healthy

Interventions

pulmonary hypertension OTHER

The final outcome observed was a diagnosis of pulmonary hypertension.

pulmonary hypertension

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a observational prospective longitudinal cohort study to to establish the large PH cohort and biological database in China, including PH subjects( n= 5000) and healthy subjects (n= 5000). Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct right heart catheterization(RHC). Patients must meet all the inclusion criteria and none of the exclusion criteria. No additional investigational drugs will be applied to the patients. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and R software. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zili Zhang

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 25, 2023
• Study Start: July 12, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)