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Pulmonary Hypertension (PH) Biorepository for Translational Research

13. juni 2026 opdateret af: National Institutes of Health Clinical Center (CC)

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Medical Center (UMMC) at Baltimore
      • Bethesda, Maryland, Forenede Stater, 20892
        • National Institutes of Health Clinical Center
        • Kontakt:
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • Telefonnummer: TTY dial 711 800-411-1222
          • E-mail: ccopr@nih.gov
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The study population will consist of adult male and female participants older than 18 years who are suspected of having or have been diagnosed with pulmonary hypertension (PH). Eligible individuals must be able to understand the study requirements and be willing to provide written informed consent by signing and dating the informed consent form prior to participation.

Beskrivelse

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Group 1 (suspected of or diagnosed)
Pulmonary Arterial Hypertension, PAH
Group 2 (suspected of or diagnosed)
PH due to left heart disease
Group 3 (suspected of or diagnosed)
PH due to lung diseases and/or hypoxia
Group 4 (suspected of or diagnosed)
PH due to thromboembolic disease
Group 5 (suspected of or diagnosed)
PH with unclear or multifactorial mechanisms

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Develop a multi-center biorepository.
Tidsramme: 10 years
Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.
10 years

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institutes of Health Clinical Center (CC)

Efterforskere

  • Ledende efterforsker: Michael A Solomon, M.D., National Institutes of Health Clinical Center (CC)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

3. august 2026

Primær færdiggørelse (Anslået)

1. juni 2036

Studieafslutning (Anslået)

1. juni 2036

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2026

Sidst verificeret

11. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10002634
  • 002634-CC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD that underlie results in a publication.

IPD-delingstidsramme

Within 12 months from publication

IPD-delingsadgangskriterier

Published IPD will be shared upon request to the research team.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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