Leg Fluid Shift in Patients With Chronic Heart Failure and Obstructive or Central Sleep Apnea

Heart and Diabetes Center North-Rhine Westfalia

Status: Completed

Conditions: Central Sleep Apnoea; Obstructive Sleep Apnoea; Cheyne Stokes Respiration

Treatments: Diagnostic Test: Polysomnography/Polygraphy (PSG/PG); Diagnostic Test: Tilting Table with Hemodynamic Monitoring; Diagnostic Test: Capillary Blood Gas Analysis (CBGA); Diagnostic Test: Multi Frequency Bioimpedance Analysis (mfBIA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03092388

HDZNRW-KA_004_TB

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Study Group Basic

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Capillary Blood Gas Analysis (CBGA)

Diagnostic Test: Multi Frequency Bioimpedance Analysis (mfBIA)

Diagnostic Test: Polysomnography/Polygraphy (PSG/PG)

Study Group Extended

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Capillary Blood Gas Analysis (CBGA)

Diagnostic Test: Multi Frequency Bioimpedance Analysis (mfBIA)

Diagnostic Test: Tilting Table with Hemodynamic Monitoring

Diagnostic Test: Polysomnography/Polygraphy (PSG/PG)