Sleep Disordered Breathing in Patients With Chronic Heart Failure

NCT00863421 | Unknown DMC

• 1 other identifier: VISIFA 08-058-0508
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep-disordered Breathing; Chronic Heart Failure

Keywords

Sleep disordered breathing; Prevalence; Chronic heart failure; Incidence; Sleep apnea; Cheyne-Stokes-Breathing

Outcome Measures

Primary Outcomes (1)

• Prevalence of sleep disordered breathing in patients with stable chronic heart failure

  2 years

Secondary Outcomes (7)

• 2-year-incidence of sleep disordered breathing in patients with stable chronic heart failure

  2 years

• Prevalence of lung function abnormalities in patients with stable chronic heart failure

  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.

  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

  2 years

• Exercise capacity in meters in the total study population using the 6-Minute-Walking-Test distance

  2 years

Eligibility Criteria

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

Study Population

Participants will be recruited from 4 independent heart failure outpatient clinics in Vienna.

You may qualify if:

• Stable chronic heart failure(NYHA II-IV), defined as
• by the absence of any hospitalizations during the previous 3 month
• Ejection fraction equal or below 35%
• Age between 18 and 80 years

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology: lead

Study Sites (1)

Otto Wagner Hospital

Vienna, Vienna, 1140, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Sleep Apnea Syndromes; Cheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arschang Valipour, M.D.

  Ludwig Boltzmann Institute for COPD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arschang Valipour, M.D.

CONTACT

+43-1-91060-41008; arschang.valipour@wienkav.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: March 15, 2009
• First Posted: March 18, 2009
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

AU (1)