NCT03977428

Brief Summary

The study will recruit and follow up patients for five years patients newly diagnosed with congenital heart disease associated pulmonary arterial hypertension(CHD-PAH) from the investigator's hospital. The main aim of the study is to describe the aetiology, natural history and management practices of CHD-PAH in central China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 14, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

June 4, 2019

Last Update Submit

April 11, 2021

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • survival

    To recruit a cohort of CHD-PAH cases. define the death as the primary outcome

    5 years

Secondary Outcomes (1)

  • clinical worsening

    5 years

Interventions

standard of careOTHER

No intervention, this a patient registry and is purely an observational study

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with diagnosis of CHD-PAH

You may qualify if:

  • Clinical diagnosis of CHD-PAH (by RHC)

You may not qualify if:

  • PAH due to other criteria;
  • unable to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Asian Heart Hospital

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Qiu Qiu

    Wuhan Asian Heart Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Xuan

CONTACT

+8618627885144soniazheng@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 6, 2019

Study Start

January 1, 2019

Primary Completion

December 30, 2022

Study Completion

June 30, 2023

Last Updated

April 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)