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Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program (PAH QuERI Ext)

14. august 2018 opdateret af: Actelion
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

To improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (defined as: 1) improvement of FC III or IV to FC II; 2) improvement of FC II to FC I; or 3) maintaining FC II or I)

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

797

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35216
        • Cardiovascular Associates, Pc
      • Mobile, Alabama, Forenede Stater, 36617
        • University of South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Pulmonary Associates
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Fountain Valley, California, Forenede Stater, 92866
        • Alliance Medical and Research Center
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Clinic, Scripps Green Hospital
      • Los Angeles, California, Forenede Stater, 90033
        • University of Southern California
      • San Juan Capistrano, California, Forenede Stater, 92675
        • Paloma Medical Group
      • Torrance, California, Forenede Stater, 90502
        • Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Denver
      • Littleton, Colorado, Forenede Stater, 80120
        • South Denver Cardiology Associates PC
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Robert E. Benkert, M.D.P.C.
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Lung Health & Sleep Enhancement Center, LLC
    • Florida
      • Brandon, Florida, Forenede Stater, 33511
        • Bay Area Cardiology Research, P.A.
      • Clearwater, Florida, Forenede Stater, 33756
        • Bay Area Chest Physicians
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward Pulmonary and Sleep Specialists
      • Fort Lauderdale, Florida, Forenede Stater, 33334
        • Pulmonary Diseases, Internal Medicine, Critical Care Medicine
      • Miami Beach, Florida, Forenede Stater, 33140
        • Mount Sinai Medical Centre - Columbia University - Division of Cardiology
      • Orlando, Florida, Forenede Stater, 32803
        • Central Florida Pulmonary Group, PA
      • Sarasota, Florida, Forenede Stater, 34239
        • Lung Associates of Sarasota
      • Weston, Florida, Forenede Stater, 33331
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago
      • Peoria, Illinois, Forenede Stater, 61602
        • Unity Point Health Pulmonary Services
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52301
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Kentuckiana Pulmonary Associates
      • Louisville, Kentucky, Forenede Stater, 40202
        • University of Louisville School of Medicine
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center
    • Maine
      • Portland, Maine, Forenede Stater, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Medical Centre
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Pulmonary Hypertension Program
      • Detroit, Michigan, Forenede Stater, 48324
        • Wayne State University, Detroit Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49525
        • Spectrum Health
      • Troy, Michigan, Forenede Stater, 48085
        • William Beaumont Hospital - Troy
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68506
        • Nebraska Pulmonary Specialties, LLC
      • Omaha, Nebraska, Forenede Stater, 68131
        • Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division
      • Omaha, Nebraska, Forenede Stater, 68198-5300
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
        • The Lung Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Bloomfield, New Jersey, Forenede Stater, 07003
        • Michael Schwarz, MDFACC
      • Hawthorne, New Jersey, Forenede Stater, 07506
        • Respiratory Health & Critical Care Associates
      • Newark, New Jersey, Forenede Stater, 07112
        • Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center
    • New York
      • New Hyde Park, New York, Forenede Stater, 11040
        • North Shore - LIJ Health System
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina University
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Phyisicans Clinic/Pulmonary
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Christ Hospital Heart & Vascular Center
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University of Cincinnati Pulmonary Critical Care & Sleep Medicine
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Case Medical Center
      • Dayton, Ohio, Forenede Stater, 45215
        • Dayton Respiratory Center
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo Health Sciences Campus
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Heart Center Cardiology
    • Pennsylvania
      • Doylestown, Pennsylvania, Forenede Stater, 18901
        • Central Bucks Specialists - The Pavilion at Doylestown Hospital
      • Langhorne, Pennsylvania, Forenede Stater, 19007
        • Institute for Respiratory and Sleep Medicine
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • Respiratory Specialists
      • York, Pennsylvania, Forenede Stater, 17402
        • Wellspan Lung, Sleep and Critical Care
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57103
        • Sioux Falls Cardiovascular PC
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37919
        • StatCare Pulmonary Consultants
    • Texas
      • El Paso, Texas, Forenede Stater, 79902
        • El Paso Respiratory and Sleep Consultants
      • Galveston, Texas, Forenede Stater, 77555
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • UT Health - University of Texas Houston
      • Waco, Texas, Forenede Stater, 76712
        • Providence Health Center
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • IHVI, Advanced Lung Disease and Transplant Clinic
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Medical Group
    • Washington
      • Puyallup, Washington, Forenede Stater, 98372
        • Cardiac Study Center
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • PAH Clinic CPR at Auxilio Mutuo

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.

Beskrivelse

Inclusion Criteria:

  1. Male and female adults (≥ 18 years of age)

  2. Documented diagnosis of PAH (all of the following): i. RHC demonstrating mPAP > 25 mm Hg and PCWP

    ≤ 15 and PVR > 3 ii. FEV 1 > 50% predicted normal iii. V/Q and/or CT scan excluding the thromboembolic etiology

  3. Diagnosis of PAH < 3 years
  4. Need for PAH specific treatment
  5. Desire to participate and signs an informed consent

Exclusion Criteria:

Any of the criteria below:

  1. Poor mental function, drug or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
  2. Prior participation in this program
  3. Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Standard of care
Observational study to improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (FC) treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi.
Medicin: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients achieving guideline-recommended treatment
Tidsramme: 3 years
Proportion of patients achieving guideline-recommended treatment
3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients achieving optimal functional class
Tidsramme: 3 years
Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm
3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Actelion

Samarbejdspartnere

Canadian Heart Research Centre

Efterforskere

  • Studiestol: Vallerie McLaughlin, MD, University of Michigan

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

1. juni 2011

Primær færdiggørelse (Faktiske)

10. april 2018

Studieafslutning (Faktiske)

10. april 2018

Datoer for studieregistrering

Først indsendt

6. juli 2011

Først indsendt, der opfyldte QC-kriterier

7. juli 2011

Først opslået (Skøn)

8. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AC-052-428

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

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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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mauritius

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner