Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome (SAS-HTA)
30. september 2008 opdateret af: University Hospital, Grenoble
Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome : Role of Hypertension
Patients with obstructive sleep apnea syndrome have permanent variations of their hemodynamic parameters during the night : heart rate, arterial blood pressure, cardiac output.
This is due to the repetition of respiratory events (obstructive apnea and hypopnea) leading to frequent micro-arousals.
These disorders have several consequences : hypertension, NO-dependent vasodilatation impairment, baroreceptor reflex impairment, insulin resistance and other cardiovascular impairments.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Objective of the study is to characterize the cardiovascular phenotype of patients with obstructive sleep apnea syndrome, relative to the presence of hypertension or not. Hypertension should not have been previously treated. 2 groups of apneic patients (SAS+HTA+ and SAS+HTA-) will be compared together, referred to group of non apneic but hypertensive patients (SAS-HTA+) and non apneic / non hypertensive patients (SAS-HTA-).
Apneic and hypertensive patients may have a sympathetic nervous system activation and a much more important vascular and baroreceptor reflex impairment, than non apneic but hypertensive patients.
During the study, a second visit as control will be done for apneic patients only, 3 to 6 months after SAS treatment setting.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
300
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Isère
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Grenoble, Isère, Frankrig, 38000
- Rekruttering
- Cardiology and hypertension service
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Kontakt:
- Jean-Philippe JB BAGUET, PhD
- Telefonnummer: 64226 0033476764226
- E-mail: JBaguet@chu-grenoble.fr
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Kontakt:
- Jean-Louis JP PEPIN, PhD
- Telefonnummer: 68473 0033476768473
- E-mail: JPepin@chu-grenoble.fr
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-
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
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patients with or without obstructive sleep apnea syndrome (AHI > 15)
- patients with or without hypertension
Exclusion Criteria:
- known or expected secondary hypertension
- pathologies with consequences on arterial blood pressure regulation: Parkinson's disease, patients with renal or cardiac graft, severe heart failure
- drugs with consequences on arterial blood pressure regulation : vasoconstrictors, vasodilatators, béta-agonists, antagonists, nitrites, theophylline, dipyridamol, sildenafil, immunosuppressors, IMAO, neuroleptics, tricyclic antidepressants, corticoids or long-term oral (>10 days) non steroidal anti-inflammatory drugs, oestroprogestative treatments
- atrial fibrillation, frequent extrasystoles (> or = to 10/minute)
- bedridden patients
- night shift workers
- surgical or carotid stenting history
- subjects unwilling or unable to provide written, signed and dated informed consent
- patient previously treated for obstructive sleep apnea syndrome (positive airway pressure, forward mandible prosthesis, maxillofacial surgery
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: SAS+HTA+
Obstructive sleep apnea syndrome and hypertension
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Positive airway pressure treatment as long as necessary
Andre navne:
|
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Eksperimentel: SAS+HTA-
non hypertensive patients with obstructive sleep apnea syndrome
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Positive airway pressure treatment as long as necessary
Andre navne:
|
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Eksperimentel: SAS-HTA+
hypertensive patients without obstructive sleep apnea syndrome
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No treatment
Andre navne:
|
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Eksperimentel: SAS-HTA-
non hypertensive patients without obstructive sleep apnea syndrome
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No treatment
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
cardiovascular phenotype study in patients with non treated obstructive sleep apnea syndrome
Tidsramme: 6 years
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6 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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characterization of arterial blood pressure, sympathetic activity, functional and morphological cardiovascular modifications. Effect of a treatment of obstructive sleep apnea syndrome on those different parameters.
Tidsramme: 6 years
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6 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jean-Philippe JB BAGUET, PhD, University Hospital, Grenoble
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
- Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
- Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.
- Pankow W, Nabe B, Lies A, Becker H, Kohler U, Kohl FV, Lohmann FW. Influence of sleep apnea on 24-hour blood pressure. Chest. 1997 Nov 5;112(5):1253-8. doi: 10.1378/chest.112.5.1253.
- Portaluppi F, Provini F, Cortelli P, Plazzi G, Bertozzi N, Manfredini R, Fersini C, Lugaresi E. Undiagnosed sleep-disordered breathing among male nondippers with essential hypertension. J Hypertens. 1997 Nov;15(11):1227-33. doi: 10.1097/00004872-199715110-00006.
- Calver A, Collier J, Moncada S, Vallance P. Effect of local intra-arterial NG-monomethyl-L-arginine in patients with hypertension: the nitric oxide dilator mechanism appears abnormal. J Hypertens. 1992 Sep;10(9):1025-31.
- Strohl KP, Novak RD, Singer W, Cahan C, Boehm KD, Denko CW, Hoffstem VS. Insulin levels, blood pressure and sleep apnea. Sleep. 1994 Oct;17(7):614-8. doi: 10.1093/sleep/17.7.614.
- Landsberg L. Hyperinsulinemia: possible role in obesity-induced hypertension. Hypertension. 1992 Jan;19(1 Suppl):I61-6. doi: 10.1161/01.hyp.19.1_suppl.i61.
- Carlson JT, Hedner JA, Sellgren J, Elam M, Wallin BG. Depressed baroreflex sensitivity in patients with obstructive sleep apnea. Am J Respir Crit Care Med. 1996 Nov;154(5):1490-6. doi: 10.1164/ajrccm.154.5.8912770.
- Baguet JP, Mallion JM, Moreau-Gaudry A, Noirclerc M, Peoc'h M, Siche JP. Relationships between cardiovascular remodelling and the pulse pressure in never treated hypertension. J Hum Hypertens. 2000 Jan;14(1):23-30. doi: 10.1038/sj.jhh.1000933.
- Baguet JP, Barone-Rochette G, Levy P, Vautrin E, Pierre H, Ormezzano O, Pepin JL. Left ventricular diastolic dysfunction is linked to severity of obstructive sleep apnoea. Eur Respir J. 2010 Dec;36(6):1323-9. doi: 10.1183/09031936.00165709. Epub 2010 Jun 18.
- Baguet JP, Nadra M, Barone-Rochette G, Ormezzano O, Pierre H, Pepin JL. Early cardiovascular abnormalities in newly diagnosed obstructive sleep apnea. Vasc Health Risk Manag. 2009;5:1063-73. doi: 10.2147/vhrm.s8300. Epub 2009 Dec 29.
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. marts 2001
Primær færdiggørelse (Forventet)
1. december 2003
Studieafslutning (Forventet)
1. december 2008
Datoer for studieregistrering
Først indsendt
30. september 2008
Først indsendt, der opfyldte QC-kriterier
30. september 2008
Først opslået (Skøn)
1. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. oktober 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. september 2008
Sidst verificeret
1. januar 2001
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DGS2001/0398
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 .