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Pulmonary Hypertension (PH) Biorepository for Translational Research

Pulmonary Hypertension (PH) Biorepository for Translational Research

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07647549
Enrollment
1000
Registered
2026-06-15
Start date
2026-09-22
Completion date
2036-06-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension, Biorepository

Brief summary

Background: Pulmonary hypertension (PH) is high blood pressure in the blood vessels of the lungs. It can lead to heart failure and death if not treated. Researchers want to create a repository of blood samples and health information collected from people with PH. They hope to use this information to find better ways to diagnose and treat PH. Objective: To collect blood samples and health information from people suspected of or diagnosed with PH. Eligibility: People aged 18 years and older who have or may have PH. Design: Researchers will collect information from participants medical records. Participants will have blood drawn from a vein. About 3 tablespoons will be collected during the study visit. The visit will last about 1 hour. Participants may choose to provide new blood samples at follow-up visits. Updated medical information may also be collected. Participants may continue to participate as long as the study is ongoing. Participants may opt out of providing new blood samples but remain in the study. All study samples will be stored at the National Institutes of Health. Health information will be stored in secure databases.

Detailed description

Study Description: This study aims to establish a biorepository based on the World Symposium Pulmonary Hypertension (PH) Groups 1-5. In the future, IRB approved protocols may use these blood samples to discover novel, biologically relevant, non-invasive PH biomarkers. In combination with clinical data these potential biomarkers will be used to distinguish PH groups, elucidate underlying molecular phenotypes, predict clinically relevant outcomes, as well as discriminate healthy (healthy subjects will not be enrolled under this protocol) from PH disease states, and differentiate patients with PH from patients without PH. To this end, multimodal genomic, metabolomic, and proteomic assays will eventually be developed and used. Objectives: Primary: Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5. Secondary: Collect the specific data attributes that may be used in the future to determine whether multimodal genomic, metabolomic or proteomic biomarkers, in combination with clinical data, can: -Elucidate molecular phenotypes that distinguish between patients across PH groups Predict clinically relevant outcomes (i.e., disease severity, disease progression, response to therapy, transplant free survival).

Interventions

None listed

Sponsors

National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: * Provision of signed and dated informed consent form * Males and females aged \>=18 years old * Suspected of or diagnosed with PH * Able to understand and willing to sign a written informed consent document

Exclusion criteria

Any individual who does not meet all inclusion criteria or is deemed by the local investigator not to be a blood draw candidate will be excluded from participating in this study.

Design outcomes

Primary

MeasureTime frameDescription
Develop a multi-center biorepository.10 yearsDevelop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.

Secondary

MeasureTime frameDescription
Collect the specific data attributes in combination with clinical data to be used in the future to determine multimodal genomic, metabolomic or proteomic biomarkers.10 yearsThis research may predict clinically relevant outcomes. Elucidate molecular phenotypes that distinguish between patients across PH groups

Countries

United States

Contacts

CONTACTMichael A Solomon, M.D.
msolomon@cc.nih.gov(301) 496-9320
PRINCIPAL_INVESTIGATORMichael A Solomon, M.D.

National Institutes of Health Clinical Center (CC)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026