Sleep Disordered Breathing in Patients With Chronic Heart Failure (VISIFA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00863421|
Recruitment Status : Unknown
Verified June 2011 by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology.
Recruitment status was: Recruiting
First Posted : March 18, 2009
Last Update Posted : June 16, 2011
|Condition or disease|
|Sleep-disordered Breathing Chronic Heart Failure|
Chronic heart failure is a complex clinical syndrome that can result from any structural or functional cardiac or non-cardiac disorder that impairs the ability of the heart to respond to physiological demands for increased cardiac output. Chronic heart failure is characterised by symptoms such as exertional breathlessness and fatigue, and signs of fluid retention as well as signs associated with the underlying cardiac disorder. Patients with chronic heart failure suffer from reduced quality of life and a significantly higher risk of morbidity and mortality.
There is cumulating evidence of a high prevalence of sleep breathing disorders in both patients with acute and chronic heart failure. Most of these reports, however, suffer from important limitations including small sample size, retrospective study design, and/or use of pulse-oximetry or cardio-respiratory polygraphy to screen for sleep disordered breathing rather than full-night polysomnography. Hence, previous studies may have underestimated the full scale of concomitant sleep disordered breathing in patients with chronic heart failure. Furthermore, to the best of our knowledge, there is no report on the incidence of sleep disordered breathing in patients with chronic heart failure.
In this context the presence of sleep disordered breathing in patients with chronic heart failure has important prognostic relevance. Pathophysiological effects of sleep apnea include intermittent hypoxia, sympathetic hyperactivity, systemic inflammation, and sleep fragmentation. These factors may contribute to the worsening of cardiac function and explain the reportedly higher risk of cardiac morbidity and mortality in patients with both chronic heart failure and concomitant sleep disordered breathing. Accordingly, the aims of the present study are three-fold. First, to investigate the prevalence of sleep breathing disorders in patients with stable moderate-to-severe chronic heart failure using the diagnostic gold standard of full-night-polysomnography. Second, to assess the two-year incidence of sleep disordered breathing in patients with chronic heart failure. Third, to identify potential risk factors associated with the presence or absence of sleep disordered breathing in patients with chronic heart failure. The latter will be assessed by using lung function measurements, hemodynamic parameters, and laboratory markers of neurohumoral activation, systemic inflammation, and endothelial function in patients with chronic heart failure.
For this purpose 200 patients with stable moderate-to-severe chronic heart failure will be studied during a 2 year-period. Patients with chronic heart failure will be screened for eligibility during their regular visits at 4 independent heart failure outpatients clinic in Vienna. Eligible patients will undergo full-night-polysomnography, lung function testing, non-invasive hemodynamic monitoring, a six minute-walking-test, and laboratory measurements at 6 months intervals for a total of 2 years (4 visits).
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Prevalence, Incidence and Clinical Characteristics of Sleep Disordered Breathing in Patients With Stable Chronic Heart Failure|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
- Prevalence of sleep disordered breathing in patients with stable chronic heart failure [ Time Frame: 2 years ]
- 2-year-incidence of sleep disordered breathing in patients with stable chronic heart failure [ Time Frame: 2 years ]
- Prevalence of lung function abnormalities in patients with stable chronic heart failure [ Time Frame: 2 years ]
- Quality of Life in patients with and those without sleep disordered breathing using the Minnesota Living With Heart Failure Questionnaire and the SF-36. [ Time Frame: 2 years ]
- Sleep Quality in patients with and those without sleep disordered breathing using the Pittsburgh Sleep Quality Index, the Sleep Disorders Questionnaire, and the Functional Outcome of Sleep Questionnaire [ Time Frame: 2 years ]
- Exercise capacity in meters in the total study population using the 6-Minute-Walking-Test distance [ Time Frame: 2 years ]
- Pro brain natriuretic peptide, C-reactive protein, tumor-necrosis-factor alpha, interleukin-6, asymmetric dimethylarginine, vascular endothelial growth factor [ Time Frame: 2 years ]
- Measurements of cardiac output, heart rate variability, and baroreceptor sensitivity [ Time Frame: 2 years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863421
|Contact: Arschang Valipour, M.D.||+email@example.com|
|Otto Wagner Hospital||Recruiting|
|Vienna, Austria, 1140|
|Contact: Arschang Valipour, M.D. +43-1-91060-41008 firstname.lastname@example.org|
|Principal Investigator: Arschang Valipour, M.D.|
|Principal Investigator:||Arschang Valipour, M.D.||Ludwig Boltzmann Institute for COPD|