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The PAH Platform for Deep Phenotyping in Korean Subjects (PHOENIKS)

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ClinicalTrials.gov Identifier: NCT03933579
Recruitment Status : Unknown
Verified April 2019 by Wook-Jin Chung, Gachon University Gil Medical Center.
Recruitment status was:  Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Sejong General Hospital
Chonnam National University Hospital
Keimyung University Dongsan Medical Center
Saint Vincent's Hospital, Korea
Seoul National University
Chungnam National University Hospital
Wonju Severance Christian Hospital
Asan Medical Center
Wonkwang University Hospital
Chungbuk National University Hospital
Samsung Medical Center
Severance Hospital
The Catholic University of Korea
Seoul National University Bundang Hospital
Pusan National University Hospital
Chonbuk National University Hospital
Pusan National University Yangsan Hospital
Information provided by (Responsible Party):
Wook-Jin Chung, Gachon University Gil Medical Center

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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Deep Phenotyping Idiopathic Pulmonary Arterial Hypertension Heritable Pulmonary Arterial Hypertension Diagnostic Test: Deep phenotyping

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Nation-wide 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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020



Intervention Details:
  • Diagnostic Test: Deep phenotyping
    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.


Primary Outcome Measures :
  1. Composite outcomes of death and hospitalization [ Time Frame: 3 years ]
    A composite of death and hospitalization


Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 3 years ]
    6 minute walk test


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic PAH and heritable PAH patients in Korea
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933579


Contacts
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Contact: Wook-Jin Chung, MD 82-32-460-3663 heart@gilhospital.com
Contact: Albert Y Jang, MD 82-32-460-3663 cardio_gil@gilhospital.com

Locations
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Korea, Republic of
Department of Cardiovascular Medicine, Gachon University, Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Mi Ju Yu, BS       miju21@gilhospital.com   
Contact: Gyeong-Lim Hyun, BS       gcri.kr@gmail.com   
Sponsors and Collaborators
Gachon University Gil Medical Center
Sejong General Hospital
Chonnam National University Hospital
Keimyung University Dongsan Medical Center
Saint Vincent's Hospital, Korea
Seoul National University
Chungnam National University Hospital
Wonju Severance Christian Hospital
Asan Medical Center
Wonkwang University Hospital
Chungbuk National University Hospital
Samsung Medical Center
Severance Hospital
The Catholic University of Korea
Seoul National University Bundang Hospital
Pusan National University Hospital
Chonbuk National University Hospital
Pusan National University Yangsan Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wook-Jin Chung, Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT03933579    
Other Study ID Numbers: WJC-IIT-1002
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are planning to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases