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This study aims to investigate the influence of a potential leg fluid shift (LFS) in patients with chronic heart failure (CHF) and obstructive sleep apnea (OSA) or central sleep apnea (CSA).
Chronic heart failure (CHF) is a common disease in general western population with high levels of morbidity and mortality. Prospective risk factors need to be identified and investigated. The prevalence for sleep disordered breathing (SDB) in patients with CHF is higher compared to general population. Especially the occurence of CSA with its special breathing pattern of Cheyne-Stokes-Respiration (CSR) is frequent in CHF patients.The pathophysiology and relation inbetween sleep apnea (SA) and CHF isn´t completely identified yet. Multiple theories with different strategies try to explain the pathophysics and development of SA. Following one of these theories, patients with CHF often develop edema in lower body compartments. The idea is a possible influence of retrograde nocturnal LFS from lower body to upper body compartments which could induce pulmonal congestion. Therefore, an increased pulmonary capillary wedge pressure (PCWP) could irritate special pulmonal receptors resulting in CSR with periods of hyperventilation, related hypocapnia and central apnea events. OSA could be induced by fluid accumulation in the upper airway by retrograde fluid shift.
Patients with known CHF receive fluid measurements by b multi frequency bioimpedance analysis (mfBIA) the evening before and the morning after sleep is recorded using polygraphy (PG) or polysomnography (PSG) in hospital. Sleep results are analyzed by physicians using current guidelines of the American Academy of Sleep Medicine (AASM).
Capillary blood gas (CBG) samples are taken before and after sleep to examine the relation of fluid shift and blood gas changes.
A subgroup of the study group undergo additional investigation. Hemodynamic effects (e.g. reduced cardiac output (CO)) as a cause of a potential fluid shift is measured during wakefulness by using a tilting table. Hemodynamically relevant parameters are recorded non-invasively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group Basic | Experimental | Patients receive Multi Frequency Bioimpedance Analysis (mfBIA) before and after sleep recording by Polysomnography/Polygraphy (PSG/PG) in hospital. Capillary Blood Gas Analysis (CBGA) is performed before and after sleep according to mfBIA. |
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| Study Group Extended | Experimental | Patients receive Multi Frequency Bioimpedance Analysis (mfBIA) before and after sleep recording by Polysomnography/Polygraphy (PSG/PG) in hospital. Capillary Blood Gas Analysis (CBGA) is performed before and after sleep according to mfBIA. Additionally, during daytime a special test with random parts of the study group basic is performed: A tilting table with hemodynamic monitoring is used to induce an artificial LFS by moving patients from vertical into horizontal position. Bodyfluid changes are monitored by mfBIA during this procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi Frequency Bioimpedance Analysis (mfBIA) | Diagnostic Test | Multi Frequency Bioimpedance Analysis (mfBIA) uses very small electric current at different frequencies (5, 50, 100 kHz) to measure the resistance and reactance of the entire body and different segmental body compartiments. With a special software total body fluid can be calculated. By analyzing raw data at different frequencies a detailed view on body and segments fluid distribution is possible. |
| Measure | Description | Time Frame |
|---|---|---|
| ∆ Leg Fluid Shift (LFS) | [%] Difference between the raw data of leg fluid volume before and after sleep. | one night |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea-Index (AHI) | [/h], definition after current AASM guideline | one night |
| Cheyne-Stokes-Respiration | [min] + [(%) of Total Sleep Time (TST)] |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index | [(l/min)/m²] Cardiac output from left ventricle related to body surface during tilting table | one hour |
| ∆ pcCO2 | [mmHG] Difference of pcCO2 before and after tilting table |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bitter, MD | Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany | Study Director |
| Schindhelm Florian | Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart - and Diabetes CenteHerz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen | Bad Oeynhausen | North - Rhine Westfalia | 32545 | Germany |
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|
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| Polysomnography/Polygraphy (PSG/PG) | Diagnostic Test | Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines. |
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| Capillary Blood Gas Analysis (CBGA) | Diagnostic Test | CBGA is a less invasive method to gain arterial blood like gas samples without the punctation of an artery. After inducing a good capillary perfusion, capillary blood is taken by a small punctation of the tip of one ear. The sample is automatically analysed in a blood gas analyzer. |
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| Tilting Table with Hemodynamic Monitoring | Diagnostic Test | A tilting table offers the opportunity to turn a study subject automatically from vertical into horizontal position and back. By using non-invasive monitoring technique, hemodynamic parameters are recorded permanently. |
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| one night |
| Oxygen-Desaturation-Index (ODI) | [/h], definition after current AASM guideline | one night |
| Time Oxygen Saturation < 90% (TSpO2<90%) | [min] + [% (of TST)] | one night |
| Oxygen Saturation (SpO2) | one night |
| Sleep Efficiency | one night |
| Longest Apnea time | [min] | one night |
| Longest Hypopnea time | [min] | one night |
| ∆ partial pressure in capillary blood of carbon dioxide (pcCO2) | [mmHG] Difference of pcCO2 before and after sleep | one night |
| ∆ partial pressure in capillary blood of oxygen (pcO2) | [mmHG] Difference of pcO2 before and after sleep | one night |
| ∆ Resistance | [Ohm] | one night |
| ∆ Reactance | [Ohm] | one night |
| ∆ Total Body Water (TBW) | [l] | one night |
| Blood Pressure (systolic, diastolic, mean) | [mmHg] | one night |
| one hour |
| ∆ pcO2 | [mmHG] Difference of pcO2 before and after sleep | one hour |
| Thoracic Fluid Content (TFC) | [1/kOhm] | one hour |
| ∆ Leg Fluid Shift | [%] Difference between the raw data of leg fluid volume before and after tilting table. | one hour. |
| ∆ Total Body Water | [l] | one hour |
| Oxygen Saturation | one hour |
| Blood Pressure (systolic, diastolic and mean) | [mmHg] | one hour |
| ∆ Resistance (legs, body) | [Ohm] electrical resistance | one hour |
| ∆ Reactance (legs, body) | [Ohm] capacitive resitance | one hour |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| D002639 | Cheyne-Stokes Respiration |
| D012891 | Sleep Apnea Syndromes |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| D000074743 | Hemodynamic Monitoring |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003935 | Diagnostic Techniques, Cardiovascular |
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