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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092388
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092388


Locations
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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
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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
Layout table for additonal 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    Key Record Dates
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:
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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