- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00701519
The Prevalence of Sleep Disordered Breathing in Hospitalized Patients With Acutely Decompensated Heart Failure Syndrome
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Congestive heart failure affects 2.3% of the population (approximately 4,900,000) with an incidence of 10 per 1,000 of the population after the age of 65 (1). The admission rate for patients with heart failure is on the rise, so is the mortality associated with it and its national annual bill, now exceeding $21 billion (1). Obstructive Sleep Apnea (OSA) is present in 11-37% of patients with heart failure (2,3), and tends to increase in severity when the heart failure is less controlled (4, 5). Therefore, the actual prevalence of OSA in patients hospitalized with acute heart failure is likely higher. There is now evidence that treatment of OSA with nasal Continuous Positive Pressure (nCPAP) in outpatients with stable heart failure improves left ventricular ejection fraction, and quality of life (6), and confers a reduction in fatal and non-fatal cardiovascular events (7). However, there has not been any evaluation of the role of diagnosis and treatment of OSA in patients hospitalized with acute heart failure. This uncertainty about the true prevalence and role of OSA in exacerbations of heart failure, and the role of its treatment in the acute setting may explain why aggressive diagnostic and therapeutic strategy for OSA in patients admitted to the hospital with acute heart failure is not part of the standard clinical practice in acute care centers. Given the rising admission rate, and mortality associated with heart failure, an evaluation of the role of OSA and its treatment in this patient population is highly significant.
The significance of this question resides mainly in the best approach to diagnosis and treatment of SDB in this high risk and vulnerable population. Should every patient wit heart failure undergo a polysomnography to diagnose a highly likely underlying SDB, and trigger appropriate treatment? The cost of polysomnography and the access to sleep laboratory makes it almost prohibitive to pursue such an approach. An approach that combines evaluation of risk factors and an abbreviated portable study may be adequate and certainly less expensive. Our OSU- Sleep Heart program was established to deliver expedient diagnosis and treatment of SDB to patients with heart failure. In the published literature, there are not adequate data to guide the delivery of Sleep services in this patient population. Our program aims at targeting every heart failure patient with validated questionnaires and screening ambulatory sleep studies. The sensitivity and specificity of such a surveillance approach will need to be evaluated against the reference standard, the polysomnography. Therefore this protocol aims to evaluate the negative and positive predictive value of our clinical program.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Ohio
-
Columbus, Ohio, Verenigde Staten, 43212
- The Ohios State University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- OSU Heart Failure Patient
- Able to Complete Survey
Exclusion Criteria:
- Neurological Deficit
- No Heart failure
- Less than 18 yrs old
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
The risk and presence of sleep apnea in heart failure out patients.
Tijdsspanne: Immediate
|
Immediate
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rami N Khayat, MD, The Ohio Sate University
Publicaties en nuttige links
Algemene publicaties
- Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.
- Sin DD, Fitzgerald F, Parker JD, Newton G, Floras JS, Bradley TD. Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med. 1999 Oct;160(4):1101-6. doi: 10.1164/ajrccm.160.4.9903020.
- Mansfield DR, Gollogly NC, Kaye DM, Richardson M, Bergin P, Naughton MT. Controlled trial of continuous positive airway pressure in obstructive sleep apnea and heart failure. Am J Respir Crit Care Med. 2004 Feb 1;169(3):361-6. doi: 10.1164/rccm.200306-752OC. Epub 2003 Nov 3.
- Solin P, Bergin P, Richardson M, Kaye DM, Walters EH, Naughton MT. Influence of pulmonary capillary wedge pressure on central apnea in heart failure. Circulation. 1999 Mar 30;99(12):1574-9. doi: 10.1161/01.cir.99.12.1574.
- 1- Heart Disease and Stroke-Statistics, American Heart Association, 2005 update
- Skinner MA, Choudhury MS, Homan SD, Cowan JO, Wilkins GT, Taylor DR. Accuracy of monitoring for sleep-related breathing disorders in the coronary care unit. Chest. 2005 Jan;127(1):66-71. doi: 10.1378/chest.127.1.66.
- Katragadda S, Xie A, Puleo D, Skatrud JB, Morgan BJ. Neural mechanism of the pressor response to obstructive and nonobstructive apnea. J Appl Physiol (1985). 1997 Dec;83(6):2048-54. doi: 10.1152/jappl.1997.83.6.2048.
- Morgan BJ, Denahan T, Ebert TJ. Neurocirculatory consequences of negative intrathoracic pressure vs. asphyxia during voluntary apnea. J Appl Physiol (1985). 1993 Jun;74(6):2969-75. doi: 10.1152/jappl.1993.74.6.2969.
- Magder SA, Lichtenstein S, Adelman AG. Effect of negative pleural pressure on left ventricular hemodynamics. Am J Cardiol. 1983 Sep 1;52(5):588-93. doi: 10.1016/0002-9149(83)90032-2.
- Stoohs R, Guilleminault C. Cardiovascular changes associated with obstructive sleep apnea syndrome. J Appl Physiol (1985). 1992 Feb;72(2):583-9. doi: 10.1152/jappl.1992.72.2.583.
- Hanly P, Sasson Z, Zuberi N, Lunn K. ST-segment depression during sleep in obstructive sleep apnea. Am J Cardiol. 1993 Jun 1;71(15):1341-5. doi: 10.1016/0002-9149(93)90552-n.
- Roebuck T, Solin P, Kaye DM, Bergin P, Bailey M, Naughton MT. Increased long-term mortality in heart failure due to sleep apnoea is not yet proven. Eur Respir J. 2004 May;23(5):735-40. doi: 10.1183/09031936.04.00060404.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2007H0055
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .