Sleep-disordered BreathingVISIFANCT00863421
Sleep Disordered Breathing in Patients With Chronic Heart Failure
An observational study of Sleep-disordered Breathing and Chronic Heart Failure, run by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology at 1 site in Austria.
Trial summary
Only few prospective studies systematically investigated the prevalence of sleep disordered breathing in patients with stable chronic heart failure. Furthermore there is no report on the incidence rate of sleep disordered breathing in this population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep-disordered Breathing, Chronic Heart Failure
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2008to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from 4 independent heart failure outpatient clinics in Vienna.
Who may be able to join
- Stable chronic heart failure(NYHA II-IV), defined as
- a condition diagnosed for at least 6 months prior to inclusion under maximally tolerated medical therapy
- without any relevant changes to symptoms or medication during the 8 weeks prior to inclusion
- by the absence of any hospitalizations during the previous 3 month
- Ejection fraction equal or below 35%
- Age between 18 and 80 years
Who cannot join
- Instable angina pectoris
- Acute coronary syndrome within the last 6 months
- Cerebrovascular events (TIA, PRIND, stroke) within the last 12 months
- Primary pulmonary hypertension(systolic PAP > 45 mmHg)
- Congenital heart failure
- Primary heart valve disease
Show all 15Show fewer
- Regular use of benzodiazepines, other sedatives, or opiate derivatives
- Severe renal(s-creatinine > 3 mg/dl) and/or liver disease(GPT > 3xULN)
- Clinically relevant affections of the central nervous system(e.g.epilepsy, multiple sclerosis,...)
- Known moderate to severe chronic obstructive pulmonary disease(FEV1/(F)VC < 70% und FEV1 < 50% Soll) or restrictive lung disease with total lung capacity < 70%
- Untreated hormonal disease(e.g.hypothyreosis,....)
- Daily alcohol consumption with more than 60g alcohol per day for men and more than 30g alcohol per day for women
- Implantation of a pacemaker or ICD within the previous 6 months
- St.p. aortocoronary bypass surgery or lung resection within the previous 12 month
- Women of child-bearing age
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Otto Wagner Hospital
Vienna, State of Vienna, 1140
Arschang Valipour, M.D., +43-1-91060-41008, arschang.valipour@wienkav.at
Arschang Valipour, M.D.
About this study
Official title: Prevalence, Incidence and Clinical Characteristics of Sleep Disordered Breathing in Patients With Stable Chronic Heart Failure
Only few prospective studies systematically investigated the prevalence of sleep disordered breathing in patients with stable chronic heart failure. Furthermore there is no report on the incidence rate of sleep disordered breathing in this population. This is a prospective multi-centre study of sleep-disordered breathing in 200 patients with stable moderate-to-severe chronic heart failure. Eligible patients will undergo overnight full-night polysomnography, lung function testing, laboratory measurements, and hemodynamic recordings. Measurements will be repeated at 6 months interval for a follow-up period of two years irrespective of the presence or absence of sleep disordered breathing. The primary outcome variable for this study is the prevalence of sleep disordered breathing in the study population. Secondary outcome variables include the 2-year incidence rate of sleep disordered breathing, quality of life measurements, exercise capacity, sleep quality, hemodynamic measurements, and laboratory markers of neurohumoral activation, systemic inflammation, and endothelial function in the study population.
Read the detailed description
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).
- Conditions
- Sleep-disordered Breathing, Chronic Heart Failure
- Keywords
- Sleep disordered breathing, Prevalence, Chronic heart failure, Incidence, Sleep apnea, Cheyne-Stokes-Breathing
- Medical subject headings
- Sleep Apnea Syndromes, Cheyne-Stokes Respiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disordered breathing in patients with stable chronic heart failure
Measured: 2 years
Secondary outcomes (7)
2-year-incidence of sleep disordered breathing in patients with stable chronic heart failure
Measured: 2 years
Prevalence of lung function abnormalities in patients with stable chronic heart failure
Measured: 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.
Measured: 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
Measured: 2 years
Exercise capacity in meters in the total study population using the 6-Minute-Walking-Test distance
Measured: 2 years
Pro brain natriuretic peptide, C-reactive protein, tumor-necrosis-factor alpha, interleukin-6, asymmetric dimethylarginine, vascular endothelial growth factor
Measured: 2 years
Measurements of cardiac output, heart rate variability, and baroreceptor sensitivity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
- Sponsor type
- Research network
- Investigators
- Arschang Valipour, M.D., Principal investigator, Ludwig Boltzmann Institute for COPD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863421
- Sponsor's protocol ID
- VISIFA 08-058-0508
- Acronym
- VISIFA
- Status last verified
- Jun 2011
- First submitted
- 15 Mar 2009
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Incidence and Clinical Characteristics of Sleep Disordered Breathing in Patients With Stable Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00863421
- Acronym / sponsor ID
- VISIFA / VISIFA 08-058-0508
- Conditions
- Sleep-disordered Breathing, Chronic Heart Failure
- Keywords
- Sleep disordered breathing, Prevalence, Chronic heart failure, Incidence, Sleep apnea, Cheyne-Stokes-Breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- LudwLudwig Boltzmann Institute for COPD and Respiratory EpidemiologyResearch network
- Study start
- Sep 2008
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Only few prospective studies systematically investigated the prevalence of sleep disordered breathing in patients with stable chronic heart failure. Furthermore there is no report on the incidence rate of sleep disordered breathing in this population. This is a prospective multi-centre study of sleep-disordered breathing in 200 patients with stable moderate-to-severe chronic heart failure. Eligible patients will undergo overnight full-night polysomnography, lung function testing, laboratory measurements, and hemodynamic recordings. Measurements will be repeated at 6 months interval for a follow-up period of two years irrespective of the presence or absence of sleep disordered breathing. The primary outcome variable for this study is the prevalence of sleep disordered breathing in the study population. Secondary outcome variables include the 2-year incidence rate of sleep disordered breathing, quality of life measurements, exercise capacity, sleep quality, hemodynamic measurements, and laboratory markers of neurohumoral activation, systemic inflammation, and endothelial function in the study population.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from 4 independent heart failure outpatient clinics in Vienna.
Key inclusion criteria (6 listed)
- Stable chronic heart failure(NYHA II-IV), defined as
- Ejection fraction equal or below 35%
- Age between 18 and 80 years
Key exclusion criteria (15 listed)
- Instable angina pectoris
- Acute coronary syndrome within the last 6 months
- Cerebrovascular events (TIA, PRIND, stroke) within the last 12 months
- Primary pulmonary hypertension(systolic PAP > 45 mmHg)
- Congenital heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of sleep disordered breathing in patients with stable chronic heart failure
Time frame: 2 years
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arschang Valipour, M.D. principal investigator
Ludwig Boltzmann Institute for COPD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-disordered Breathing and Chronic Heart Failure, run by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arschang Valipour, M.D. (+43-1-91060-41008, arschang.valipour@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sleep disordered breathing in patients with stable chronic heart failure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.