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Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension (Sommeil_HTAP)

27. marts 2013 opdateret af: Assistance Publique - Hôpitaux de Paris

Study Searching for Hypoxemic Sleep Breathing Disorders in a Cohort of Patients With Idiopathic Pulmonary Arterial Hypertension (IPAH) and Chronic Post-embolic Pulmonary Hypertension (CPEPH)

In the investigators study, and regarding results of small cohorts in the literature, the investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators will explore these patients with a one night polysomnography and transcutaneous capnography, searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Pulmonary hypertension (PH) is a rare and severe disease of young adults, characterized by a progressive increase in pulmonary vascular resistances leading to cardiac failure and death. Patients with PH are categorized in two major groups: primary PH (PPH) wich is idiopathic, and secondary PH associated with many conditions such as chronic pulmonary embolic diseases (CPED).Increase in vascular resistance in PH is secondary to vasoconstriction and to a proliferative remodeling process of the arterial wall leading to obliteration of the small arterioles. On the other hand, hypoxemia is known to cause similar changes in vascular architecture. Also, some small cohorts study in the literature mentioned an increase of sleep hypoxemia prevalence accounting for almost 70% of cases. The mechanisms of this hypoxemia are completely unknown.Our study is observational, prospective and transversal, searching for hypoxemic respiratory sleep disorders (HRSD) in PPH and in CPEPH. Included patients will have one night polysomnography (CIDELEC) with a continuous measurement of transcutaneous PCO2.The major objectives are to determine the prevalence of HRSD, their physiopathologic mechanisms and their possible causal factors according to PH history, clinical findings and hemodynamic severity.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

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

Studiesteder

      • Clamart, Frankrig, 92141
        • Assistance Publique- Hôpitaux de Paris: Antoine Beclere 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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with IPAH or CPEPH hospitalized in our pulmonary department for a standard follow-up. They have to be in a stable condition, as defined by the New York Heart Association classes for dyspnea and the six minutes walking test. Furthermore, no changes in medical therapy could have been made during the last three months.

Beskrivelse

Inclusion Criteria:

  • Patient aged 18 to 75 years
  • Patient with IPAH ot CPEPH stable for at least 3 months. Stability is defined by the New York Heart Association classes for dyspnea and the six minutes walking test (6MWT). Furthermore, no changes in medical therapy had occured during the last three months.
  • Patients who signed informed consent

Exclusion Criteria:

  • Patients with secondary PH associated with other pathologies outside CPEPH ( sclerodermia, systemic lupus erythematous, portal hypertension, chronic HIV infection...)
  • Patients who had a functional and/or a hemodynamic degradation during the last 3 months or a change in pulmonary hypertension treatment
  • Patients with obstructive or restrictive ventilatory disorder with a Ventricular Ejection Fraction <60% predicted
  • Women without effective contraception
  • Patients with a Body Mass Index above 35 kg/m2
  • Patient not affiliated to a social security scheme

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
IPAH or CPEPH
Idiopathic pulmonary arterial hypertension (IPAH) or pulmonary hypertension associated with chronic post-embolic pulmonary hypertension (CPEPH)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
hypoxemia during the night
Tidsramme: at the inclusion
prevalence of nocturnal hypoxemia in IPAH and CPEPH
at the inclusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Predictors: physical, functional and hemodynamical data
Tidsramme: at the inclusion
Predictive factors of sleep hypoxemia in IPAH and CPEPH
at the inclusion
Physiopathologic mechanisms: causes of nocturnal hypoxemia: hypoventilation, sleep disordered breathing, shunting, V/Q mismatch
Tidsramme: at the inclusion
Physiopathologic mechanisms of sleep hypoxemia in IPAH and CPEPH
at the inclusion

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Gabriel ROISMAN, MD, Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere

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.

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 2010

Primær færdiggørelse (Faktiske)

1. juli 2011

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

13. december 2010

Først indsendt, der opfyldte QC-kriterier

8. juni 2011

Først opslået (Skøn)

13. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. marts 2013

Sidst verificeret

1. marts 2013

Mere information

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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