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

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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)

Studietype

Observasjonsmessig

Registrering (Faktiske)

797

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Bare etui
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.
Legemiddel: 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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Actelion

Samarbeidspartnere

Canadian Heart Research Centre

Etterforskere

  • Studiestol: Vallerie McLaughlin, MD, University of Michigan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2011

Primær fullføring (Faktiske)

10. april 2018

Studiet fullført (Faktiske)

10. april 2018

Datoer for studieregistrering

Først innsendt

6. juli 2011

Først innsendt som oppfylte QC-kriteriene

7. juli 2011

Først lagt ut (Anslag)

8. juli 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AC-052-428

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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