Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

NCT00701038 | Completed Results

• 1 other identifier: 2005H0186
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Congestive heart failure affects 2.3 percent 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 percent 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.

Conditions

Sleep Apnea; Heart Failure

Keywords

Sleep apnea,; obstructive sleep apnea,; heart failure,; CHF

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction Improvement

  Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.

  baseline and again after three nights in hospital

Study Arms (2)

Device

EXPERIMENTAL

Provided with an auto adjusting bi-level positive airway pressure device

Device: auto adjusting bi-level positive airway pressure device

Control

NO INTERVENTION

No device

Interventions

auto adjusting bi-level positive airway pressure device DEVICE

auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.

Also known as: APAP, CPAP

Device

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide an informed consent
• Speaks English
• Older than 21
• Heart Failure
• Positive for OSA

You may not qualify if:

• CSA
• Already on CPAP
• Hemodynamic instability
• Acute respiratory failure
• Neurological defect
• Dialysis

Sponsors & Collaborators

• Rami Khayat: lead

Related Publications (14)

• Heart Disease and Stroke-Statistics, American Heart Association, 2005 update

  BACKGROUND

• 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.

  PMID: 9626176 BACKGROUND

• 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.

  PMID: 10508793 BACKGROUND

• 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.

  PMID: 15653964 BACKGROUND

• 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.

  PMID: 10096933 BACKGROUND

• 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.

  PMID: 14597482 BACKGROUND

• 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.

  PMID: 15781100 BACKGROUND

• 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.

  PMID: 9390980 BACKGROUND

• 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.

  PMID: 8365996 BACKGROUND

• 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.

  PMID: 6613883 BACKGROUND

• 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.

  PMID: 1559936 BACKGROUND

• 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.

  PMID: 8498378 BACKGROUND

• 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.

  PMID: 15176689 BACKGROUND

• Khayat RN, Abraham WT, Patt B, Pu M, Jarjoura D. In-hospital treatment of obstructive sleep apnea during decompensation of heart failure. Chest. 2009 Oct;136(4):991-997. doi: 10.1378/chest.09-0597. Epub 2009 Jun 30.

  PMID: 19567491 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Rami Khayat
• Organization: The Ohio State Universtiy

rami.khayat@osumc.edu

614-247-7707

Study Officials

• Rami N Khayat, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor-Clinical

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: August 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 4, 2013
• Results First Posted: December 14, 2011

Record last verified: 2013-01