Clinical trial NCT03092388: Leg Fluid Shift in Patients With Chronic Heart Failure and Obstructive or Central Sleep Apnea
Official title: Evaluation Eines Leg Fluid Shift Und Erörterung Der hämodynamischen Und Respiratorischen Auswirkungen Auf Patienten Mit Chronischer Herzinsuffizienz Und Obstruktiver Oder Zentraler Schlafapnoe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnoea
Central Sleep Apnoea
Cheyne Stokes Respiration
Keywords: Sleep-Disordered Breathing
Heart Failure
Leg Fluid Shift
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: ∆ Leg Fluid Shift (LFS)
timeFrame: one night
Secondary outcomes:
measure: Apnea-Hypopnea-Index (AHI)
timeFrame: one night
measure: Cheyne-Stokes-Respiration
timeFrame: one night
measure: Oxygen-Desaturation-Index (ODI)
timeFrame: one night
measure: Time Oxygen Saturation < 90% (TSpO2<90%)
timeFrame: one night
measure: Oxygen Saturation (SpO2)
timeFrame: one night
measure: Sleep Efficiency
timeFrame: one night
measure: Longest Apnea time
timeFrame: one night
measure: Longest Hypopnea time
timeFrame: one night
measure: ∆ partial pressure in capillary blood of carbon dioxide (pcCO2)
timeFrame: one night
measure: ∆ partial pressure in capillary blood of oxygen (pcO2)
timeFrame: one night
measure: ∆ Resistance
timeFrame: one night
measure: ∆ Reactance
timeFrame: one night
measure: ∆ Total Body Water (TBW)
timeFrame: one night
measure: Blood Pressure (systolic, diastolic, mean)
timeFrame: one night
Other outcomes:
measure: Cardiac Index
timeFrame: one hour
measure: ∆ pcCO2
timeFrame: one hour
measure: ∆ pcO2
timeFrame: one hour
measure: Thoracic Fluid Content (TFC)
timeFrame: one hour
measure: ∆ Leg Fluid Shift
timeFrame: one hour.
measure: ∆ Total Body Water
timeFrame: one hour
measure: Oxygen Saturation
timeFrame: one hour
measure: Blood Pressure (systolic, diastolic and mean)
timeFrame: one hour
measure: ∆ Resistance (legs, body)
timeFrame: one hour
measure: ∆ Reactance (legs, body)
timeFrame: one hour
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart - and Diabetes CenteHerz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
state: North - Rhine Westfalia
Study officials:
affiliation: Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
name: Thomas Bitter, MD
role: STUDY_DIRECTOR
affiliation: Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
name: Schindhelm Florian
role: PRINCIPAL_INVESTIGATOR
References: