Registration Study for Rare Type of Pulmonary Hypertension

September 28, 2023 updated by: Zhi-Cheng JING, MD, China National Center for Cardiovascular Diseases
The knowledge on the rare type of pulmonary hypertension which can not be explained by left heart disease, respiratory disease or congenital heart disease is very limited. Investigators aim to setup a national registration study for the rare type of pulmonary hypertension, to understand the natural history, survival, progression, genetic and environmental contributions to disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main research contents of this registration study includes:

  1. Build a baseline database of the rare type of pulmonary hypertension. Collect general information, on-set symptoms and time, laboratory examination, imaging results, right heart catheterization and treatment information.
  2. Follow up recruited patients at regular intervals（6m~1y). Collect information on change in patients condition, laboratory test and treatment.
  3. Conduct genetic testing for gene mutation related or hereditary pulmonary hypertension. Link the clinical database to genetic database.
  4. Establish bio-bank for serum/plasma, urine, stool, tissues or cells.
  5. Establish prognostic study based on the clinical follow-up and genetic database.
  6. Draw diagnostic and treatment algorithm for the rare type of pulmonary hypertension.

Controls subjects: blood sample and medical data collected once.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Xin JIANG, MD. PhD.
  • Phone Number: +861088396016
  • Email: jxcs983@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Chinese Academy of Medical Sciences Fuwai Hospital and Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Rare type of pulmonary artery hypertension

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Patients diagnosed as idiopathic pulmonary artery hypertension, hereditary pulmonary artery hypertension, hereditary hemorrhagic telangiectasia associated pulmonary artery hypertension, pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis associated pulmonary artery hypertension, cavernous transformation of portal vein associated pulmonary artery hypertension, special type of congenital heart disease associated pulmonary artery hypertension, chronic thromboembolism pulmonary hypertension.
  • All patients should have undergone right heart catheterization, diagnosed according to the guideline.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

  • Patients unwilling or unable to provide written consent for participation in the study.
  • Not suffering from the rare type of pulmonary artery hypertension;

Inclusion criteria-Controls

  • Participant is willing and able to give informed consent for participation in the study.
  • Self-reported to be healthy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Idiopathic Pulmonary Artery Hypertension
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to idiopathic pulmonary artery hypertension (PAH).
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.
Hereditary PAH
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to hereditary PAH.
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.
Hereditary Hemorrhagic Telangiectasia
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to hereditary hemorrhagic telangiectasia associated PAH.
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.
Pulmonary Veno-Occlusive Disease (PVOD)
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to PVOD.
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.
Pulmonary Capillary Hemangiomatosis
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to pulmonary capillary hemangiomatosis associated PAH
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.
Cavernous Transformation of Portal Vein
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to cavernous transformation of portal vein associated PAH
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.
CTEPH
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to chronic thromboembolism pulmonary hypertension (CTEPH).
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.
Pulmonary Takaysu Arteritis
Investigators will conduct laboratory biomarker analysis and genetic analysis to identify pathogenesis or factors related to Pulmonary Takaysu Arteritis.
Other: laboratory biomarker analysis
Laboratory results will be analysed to identify disease related biomarkers.
Genetic: Genetic analysis
Gene sequencing results will be analysed to identify disease related mutations.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Survival Rate of Participants
Time Frame: up to 10 years, at 12 months interval
up to 10 years, at 12 months interval
Lung transplantation
Time Frame: up to 10 years, at 12 months interval
up to 10 years, at 12 months interval
Change in New York Heart Association (NYHA) functional class
Time Frame: up to 10 years, at 3 months interval
up to 10 years, at 3 months interval
Change in 6 mint walk distance
Time Frame: up to 10 years, at 3 months interval
up to 10 years, at 3 months interval

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genetic alteration in participants with rare type of PH
Time Frame: Baseline
To identify the major genetic alterations in participants with rare type of PH
Baseline
Change in NT-proBNP
Time Frame: up to 10 years, at 3 months interval
up to 10 years, at 3 months interval
Change in hemodynamics
Time Frame: up to 10 years, at 6 months interval
up to 10 years, at 6 months interval
Change in cardiac function
Time Frame: up to 10 years, at 3-6 months interval
Measured by Cardiac MRI
up to 10 years, at 3-6 months interval
Pulmonary endarterectomy (PEA)
Time Frame: up to 10 years, at 6 months interval
e.g. operated versus non-operated
up to 10 years, at 6 months interval
Balloon pulmonary angioplasty (BPA)
Time Frame: up to 10 years, at 6 months interval
e.g. BPA versus non-BPA
up to 10 years, at 6 months interval
Medical treatment
Time Frame: up to 10 years, at 6 months interval
e.g. mono- versus combination therapy
up to 10 years, at 6 months interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhi-Cheng JING, MD. PhD., Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2040

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RarePH135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Consent for sharing of non identifiable study data for regulatory authorities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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