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

• ClinicalTrials.gov Identifier: NCT03092388
• Recruitment Status: Completed
• First Posted: March 27, 2017
• Last Update Posted: April 4, 2017
• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Information provided by (Responsible Party): Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnoea; Central Sleep Apnoea; Cheyne Stokes Respiration	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	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Start Date: February 2015
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

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 Name: 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 Name: 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 Name: Task Force Monitor, CNsystems, Vienna, Austria

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Apnea-Hypopnea-Index (AHI) [ Time Frame: one night ]
   [/h], definition after current AASM guideline
2. Cheyne-Stokes-Respiration [ Time Frame: one night ]
   [min] + [(%) of Total Sleep Time (TST)]
3. Oxygen-Desaturation-Index (ODI) [ Time Frame: one night ]
   [/h], definition after current AASM guideline
4. Time Oxygen Saturation < 90% (TSpO2<90%) [ Time Frame: one night ]
   [min] + [% (of TST)]
5. Oxygen Saturation (SpO2) [ Time Frame: one night ]
6. Sleep Efficiency [ Time Frame: one night ]
7. Longest Apnea time [ Time Frame: one night ]
   [min]
8. Longest Hypopnea time [ Time Frame: one night ]
   [min]
9. ∆ partial pressure in capillary blood of carbon dioxide (pcCO2) [ Time Frame: one night ]
   [mmHG] Difference of pcCO2 before and after sleep
10. ∆ partial pressure in capillary blood of oxygen (pcO2) [ Time Frame: one night ]
    [mmHG] Difference of pcO2 before and after sleep
11. ∆ Resistance [ Time Frame: one night ]
    [Ohm]
12. ∆ Reactance [ Time Frame: one night ]
    [Ohm]
13. ∆ Total Body Water (TBW) [ Time Frame: one night ]
    [l]
14. Blood Pressure (systolic, diastolic, mean) [ Time Frame: one night ]
    [mmHg]

Other Outcome Measures:

1. Cardiac Index [ Time Frame: one hour ]
   [(l/min)/m²] Cardiac output from left ventricle related to body surface during tilting table
2. ∆ pcCO2 [ Time Frame: one hour ]
   [mmHG] Difference of pcCO2 before and after tilting table
3. ∆ pcO2 [ Time Frame: one hour ]
   [mmHG] Difference of pcO2 before and after sleep
4. Thoracic Fluid Content (TFC) [ Time Frame: one hour ]
   [1/kOhm]
5. ∆ Leg Fluid Shift [ Time Frame: one hour. ]
   [%] Difference between the raw data of leg fluid volume before and after tilting table.
6. ∆ Total Body Water [ Time Frame: one hour ]
   [l]
7. Oxygen Saturation [ Time Frame: one hour ]
8. Blood Pressure (systolic, diastolic and mean) [ Time Frame: one hour ]
   [mmHg]
9. ∆ Resistance (legs, body) [ Time Frame: one hour ]
   [Ohm] electrical resistance
10. ∆ Reactance (legs, body) [ Time Frame: one hour ]
    [Ohm] capacitive resitance

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

Heart - and Diabetes CenteHerz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen

Bad Oeynhausen, North - Rhine Westfalia, Germany, 32545

Sponsors and Collaborators

Heart and Diabetes Center North-Rhine Westfalia

Investigators

• Study Director: Thomas Bitter, MD; Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
• Principal Investigator: Schindhelm Florian; Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

More Information

• Responsible Party: Thomas Bitter, Senior Physician, Heart and Diabetes Center North-Rhine Westfalia
• ClinicalTrials.gov Identifier: NCT03092388
• Other Study ID Numbers: HDZNRW-KA_004_TB
• First Posted: March 27, 2017
• Last Update Posted: April 4, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia:

Sleep-Disordered Breathing; Heart Failure; Leg Fluid Shift

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Cheyne-Stokes Respiration; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases