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

Evaluation Eines Leg Fluid Shift Und Erörterung Der hämodynamischen Und Respiratorischen Auswirkungen Auf Patienten Mit Chronischer Herzinsuffizienz Und Obstruktiver Oder Zentraler Schlafapnoe

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).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnoea; Cheyne Stokes Respiration; Central Sleep Apnoea
• Intervention / Treatment: Diagnostic test: Multi Frequency Bioimpedance Analysis (mfBIA); Diagnostic test: Polysomnography/Polygraphy (PSG/PG); Diagnostic test: Capillary Blood Gas Analysis (CBGA); Diagnostic test: Tilting Table with Hemodynamic Monitoring

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North - Rhine Westfalia
    • Bad Oeynhausen, North - Rhine Westfalia, Germany, 32545
      • Heart - and Diabetes CenteHerz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Diagnostic test: Multi Frequency Bioimpedance Analysis (mfBIA); 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.; Other Names: Nutriguard M, Data Input, Darmstadt, Germany; Diagnostic test: Polysomnography/Polygraphy (PSG/PG); Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines.; Diagnostic test: Capillary Blood Gas Analysis (CBGA); 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.
EXPERIMENTAL: 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.	Diagnostic test: Multi Frequency Bioimpedance Analysis (mfBIA); 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.; Other Names: Nutriguard M, Data Input, Darmstadt, Germany; Diagnostic test: Polysomnography/Polygraphy (PSG/PG); Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines.; Diagnostic test: Capillary Blood Gas Analysis (CBGA); 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.; Diagnostic test: Tilting Table with Hemodynamic Monitoring; 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.; Other Names: Task Force Monitor, CNsystems, Vienna, Austria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
∆ Leg Fluid Shift (LFS)	[%] Difference between the raw data of leg fluid volume before and after sleep.	one night

Secondary Outcome Measures

Outcome Measure	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)]	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Investigators: Principal Investigator: Schindhelm Florian, Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; Sleep-Disordered Breathing; Leg Fluid Shift
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Cheyne-Stokes Respiration; Sleep Apnea, Central
• Other Study ID Numbers: HDZNRW-KA_004_TB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO