Evaluation Eines Leg Fluid Shift Und Erörterung Der hämodynamischen Und Respiratorischen Auswirkungen Auf Patienten Mit Chronischer Herzinsuffizienz Und Obstruktiver Oder Zentraler Schlafapnoe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- ∆ Leg Fluid Shift (LFS)
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic Heart Failure
- •reduced left ventricular ejection fraction (LVEF) ≤ 45%
- •NYHA I - IV
Exclusion Criteria
- •current existing sleep apnoea breathing therapy
- •significant chronic obstructive pulmonary disease (COPD) Tiffenau-Index: <70%
- •respiratory insufficiency with need for a long time oxygen therapy
- •hypercapnic state in rest at day time
- •acute myocardial infarction at moment of study
- •instable angina pectoris at moment of study
- •cardiac surgery in last twelve weeks
- •stroke or TIA in last twelve weeks
- •implantable cardioverter-defibrillator, if there is no security clearance of the fabricator
- •chronic kidney disease > Stage III
Arms & Interventions
Study Group Basic
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.
Intervention: Multi Frequency Bioimpedance Analysis (mfBIA) (Diagnostic Test)
Study Group Basic
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.
Intervention: Polysomnography/Polygraphy (PSG/PG) (Diagnostic Test)
Study Group Basic
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.
Intervention: Capillary Blood Gas Analysis (CBGA) (Diagnostic Test)
Study Group Extended
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.
Intervention: Multi Frequency Bioimpedance Analysis (mfBIA) (Diagnostic Test)
Study Group Extended
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.
Intervention: Polysomnography/Polygraphy (PSG/PG) (Diagnostic Test)
Study Group Extended
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.
Intervention: Capillary Blood Gas Analysis (CBGA) (Diagnostic Test)
Study Group Extended
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.
Intervention: Tilting Table with Hemodynamic Monitoring (Diagnostic Test)
Outcomes
Primary Outcomes
∆ Leg Fluid Shift (LFS)
Time Frame: one night
\[%\] Difference between the raw data of leg fluid volume before and after sleep.
Secondary Outcomes
- Blood Pressure (systolic, diastolic, mean)(one night)
- ∆ Reactance(one night)
- Cheyne-Stokes-Respiration(one night)
- Oxygen-Desaturation-Index (ODI)(one night)
- Longest Apnea time(one night)
- Time Oxygen Saturation < 90% (TSpO2<90%)(one night)
- Longest Hypopnea time(one night)
- Oxygen Saturation (SpO2)(one night)
- ∆ Resistance(one night)
- ∆ partial pressure in capillary blood of carbon dioxide (pcCO2)(one night)
- ∆ partial pressure in capillary blood of oxygen (pcO2)(one night)
- Apnea-Hypopnea-Index (AHI)(one night)
- Sleep Efficiency(one night)
- ∆ Total Body Water (TBW)(one night)
Investigators
Thomas Bitter
Senior Physician
Heart and Diabetes Center North-Rhine Westfalia