Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 6,876
- 试验地点
- 199
- 主要终点
- Prevalence of SDB in Chronic HF Patients
研究概览
简要总结
Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.
For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.
详细描述
Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure.
Sleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure.
Objective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF.
For this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate.
Cardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be over 18
- •Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines
- •Left ventricular systolic dysfunction (LVEF ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks
- •NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
- •Patient is able to fully understand study information and signed informed consent
排除标准
- •Life expectancy < 1 year for diseases unrelated to chronic HF
- •Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months
- •CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months
- •Transient ischemic attack (TIA) or Stroke within 3 months
- •Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery
- •Acute myocarditis/pericarditis within 6 months
- •Current CPAP or bilevel therapy
结局指标
主要结局
Prevalence of SDB in Chronic HF Patients
时间窗: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility
SDB= Sleep disordered breathing; HF= Heart failure
次要结局
- Nocturia ≥3 Times/Night(1-time: At baseline nocturia was assessed 1 time (anamnesis))
- Apnoea-Hypopnea-Index(1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility)
- Male Gender(1-time single assessment at baseline)
- Left Ventricular Ejection Fraction(1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution)
- NYHA Class ≥III(At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records)
- Atrial Fibrillation(1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records)
- Body Mass Index(1-time single assessment at baseline)
- Age(1-time single assessment at baseline)
- Mean SpO2(1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility)
- Min SpO2(1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility)
- Diuretics(1-time: At baseline medication was assessed 1 time (anamnesis))
- NYHA Class >= III as Predictor for SDB in Chronic HF(1-time: At baseline physical status was assessed 1 time (anamnesis and medical records))
- Ischemic Etiology(1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.)
- Nocturnal Dyspnea(1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records)
- Medication ACE Inhibitors and/ARBs(1-time: At baseline medication was assessed 1 time (anamnesis))
- Male Gender as Predictor for SDB in Chronic HF(1-time: At baseline physical status was assessed 1 time (anamnesis and medical records))
- Oxygen Desaturation Index(1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility)
- Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF(1-time: At baseline physical status was assessed 1 time (anamnesis and medical records))
- Beta-blocker(1-time: At baseline medication was assessed 1 time (anamnesis))
- Digitalis(1-time: At baseline medication was assessed 1 time (anamnesis))
- Aldosterone Antagonists(1-time: At baseline medication was assessed 1 time (anamnesis))
- Ischemic Etiology as Predictor for SDB in Chronic HF(1-time: At baseline physical status was assessed 1 time (anamnesis and medical records))