NCT03933579

Brief Summary

A total of 16 regional hospitals will be registering clinical data and biological specimens of idiopathic pulmonary arterial hypertension (IPAH)/heritable pulmonary arterial hypertension (HPAH) patients across Korea. The diagnosis of pulmonary arterial hypertension(PAH) will be based on right heart catheterization, where PAH caused by etiology other than HPAH or IPAH will be excluded. All clinical data will be stored to a government-based online database. Each participating hospitals will be collecting whole blood from each patient, through which DNA, RNA, serum, plasma, and peripheral blood mononuclear cells will be extracted from the buffy coat layer for further multi-omics analysis.

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 Mar 2018

Typical duration 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

March 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

April 10, 2019

Last Update Submit

April 28, 2019

Conditions

Pulmonary Arterial HypertensionDeep PhenotypingIdiopathic Pulmonary Arterial HypertensionHeritable Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Composite outcomes of death and hospitalization

    A composite of death and hospitalization

    3 years

Secondary Outcomes (1)

  • 6 minute walk test

    3 years

Interventions

Deep phenotypingDIAGNOSTIC_TEST

Each participating hospitals will be collecting whole blood from each patient, through which DNA, RNA, serum, plasma, and peripheral blood mononuclear cells will be extracted from the buffy coat layer for further multi-omics analysis.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Idiopathic PAH and heritable PAH patients in Korea

You may qualify if:

  • Over 18 years
  • Mean pulmonary arterial pressure of 25mmHg or higher confirmed by right heart catheterization (RHC)
  • Pulmonary vascular resistance ≥ 240 dynes∙s∙cm-5
  • Left ventricle diastolic pressure (LVDEP) or pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg

You may not qualify if:

  • Patients with drug-induced-PAH
  • Patients with CTD, human immunodeficiency virus (HIV) infection, portal hypertension, congenital heart disease, or Schistosomiasis associated- PAH
  • Long-term responders to calcium channel blockers
  • PAH patients with overt features of venous capillaries involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, Gachon University, Gil Medical Center

Incheon, South Korea

RECRUITING

Related Publications (1)

  • Jang AY, Kim S, Park SJ, Choi H, Oh PC, Oh S, Kim KH, Kim KH, Byun K, Chung WJ; PHOENIKS Investigators. A Nationwide multicenter registry and biobank program for deep phenotyping of idiopathic and hereditary pulmonary arterial hypertension in Korea: the PAH platform for deep phenotyping in Korean subjects (PHOENIKS) cohort. Clin Hypertens. 2019 Sep 15;25:21. doi: 10.1186/s40885-019-0126-8. eCollection 2019.

    PMID: 31534782DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Each participating hospitals will be collecting whole blood from each patient, through which DNA, RNA, serum, plasma, and peripheral blood mononuclear cells will be extracted from the buffy coat layer for further multi-omics analysis.

MeSH Terms

Conditions

Pulmonary Arterial HypertensionFamilial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Wook-Jin Chung, MD

CONTACT

82-32-460-3663heart@gilhospital.com

Albert Y Jang, MD

CONTACT

82-32-460-3663cardio_gil@gilhospital.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2019

First Posted

May 1, 2019

Study Start

March 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

KR(1)