Pulmonary Hypertension Observational Study

Sponsor

The First Affiliated Hospital of Guangzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05958901

Collaborator

(none)

10,000

Enrollment

Location

53.6

Anticipated Duration (Months)

186.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Other: pulmonary hypertension

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 12, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
pulmonary hypertension	Other: pulmonary hypertension The final outcome observed was a diagnosis of pulmonary hypertension.
healthy

Arm

Intervention/Treatment

pulmonary hypertension

Other: pulmonary hypertension

The final outcome observed was a diagnosis of pulmonary hypertension.

healthy

Outcome Measures

Primary Outcome Measures

mean pulmonary arterial pressure [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

The First Affiliated Hospital of Guangzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

zili zhang, Zili Zhang, The First Affiliated Hospital of Guangzhou Medical University

ClinicalTrials.gov Identifier:

NCT05958901

Other Study ID Numbers:

Pulmonary Hypertension of GIRH

First Posted:

Jul 25, 2023

Last Update Posted:

Jul 25, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension, Pulmonary

Hypertension

Study Results

No Results Posted as of Jul 25, 2023