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

Primary Purpose

Obstructive Sleep Apnoea, Central Sleep Apnoea, Cheyne Stokes Respiration

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Multi Frequency Bioimpedance Analysis (mfBIA)
Polysomnography/Polygraphy (PSG/PG)
Capillary Blood Gas Analysis (CBGA)
Tilting Table with Hemodynamic Monitoring
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnoea focused on measuring Sleep-Disordered Breathing, Heart Failure, Leg Fluid Shift

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Study Group Basic

Study Group Extended

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Apnea-Hypopnea-Index (AHI)
[/h], definition after current AASM guideline
Cheyne-Stokes-Respiration
[min] + [(%) of Total Sleep Time (TST)]
Oxygen-Desaturation-Index (ODI)
[/h], definition after current AASM guideline
Time Oxygen Saturation < 90% (TSpO2<90%)
[min] + [% (of TST)]
Oxygen Saturation (SpO2)
Sleep Efficiency
Longest Apnea time
[min]
Longest Hypopnea time
[min]
∆ partial pressure in capillary blood of carbon dioxide (pcCO2)
[mmHG] Difference of pcCO2 before and after sleep
∆ partial pressure in capillary blood of oxygen (pcO2)
[mmHG] Difference of pcO2 before and after sleep
∆ Resistance
[Ohm]
∆ Reactance
[Ohm]
∆ Total Body Water (TBW)
[l]
Blood Pressure (systolic, diastolic, mean)
[mmHg]

Full Information

First Posted
March 21, 2017
Last Updated
March 30, 2017
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT03092388
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea, Central Sleep Apnoea, Cheyne Stokes Respiration
Keywords
Sleep-Disordered Breathing, Heart Failure, Leg Fluid Shift

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group Basic
Arm Type
Experimental
Arm 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.
Arm Title
Study Group Extended
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Multi Frequency Bioimpedance Analysis (mfBIA)
Other Intervention Name(s)
Nutriguard M, Data Input, Darmstadt, Germany
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography/Polygraphy (PSG/PG)
Intervention Description
Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines.
Intervention Type
Diagnostic Test
Intervention Name(s)
Capillary Blood Gas Analysis (CBGA)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Tilting Table with Hemodynamic Monitoring
Other Intervention Name(s)
Task Force Monitor, CNsystems, Vienna, Austria
Intervention Description
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.
Primary Outcome Measure Information:
Title
∆ Leg Fluid Shift (LFS)
Description
[%] Difference between the raw data of leg fluid volume before and after sleep.
Time Frame
one night
Secondary Outcome Measure Information:
Title
Apnea-Hypopnea-Index (AHI)
Description
[/h], definition after current AASM guideline
Time Frame
one night
Title
Cheyne-Stokes-Respiration
Description
[min] + [(%) of Total Sleep Time (TST)]
Time Frame
one night
Title
Oxygen-Desaturation-Index (ODI)
Description
[/h], definition after current AASM guideline
Time Frame
one night
Title
Time Oxygen Saturation < 90% (TSpO2<90%)
Description
[min] + [% (of TST)]
Time Frame
one night
Title
Oxygen Saturation (SpO2)
Time Frame
one night
Title
Sleep Efficiency
Time Frame
one night
Title
Longest Apnea time
Description
[min]
Time Frame
one night
Title
Longest Hypopnea time
Description
[min]
Time Frame
one night
Title
∆ partial pressure in capillary blood of carbon dioxide (pcCO2)
Description
[mmHG] Difference of pcCO2 before and after sleep
Time Frame
one night
Title
∆ partial pressure in capillary blood of oxygen (pcO2)
Description
[mmHG] Difference of pcO2 before and after sleep
Time Frame
one night
Title
∆ Resistance
Description
[Ohm]
Time Frame
one night
Title
∆ Reactance
Description
[Ohm]
Time Frame
one night
Title
∆ Total Body Water (TBW)
Description
[l]
Time Frame
one night
Title
Blood Pressure (systolic, diastolic, mean)
Description
[mmHg]
Time Frame
one night
Other Pre-specified Outcome Measures:
Title
Cardiac Index
Description
[(l/min)/m²] Cardiac output from left ventricle related to body surface during tilting table
Time Frame
one hour
Title
∆ pcCO2
Description
[mmHG] Difference of pcCO2 before and after tilting table
Time Frame
one hour
Title
∆ pcO2
Description
[mmHG] Difference of pcO2 before and after sleep
Time Frame
one hour
Title
Thoracic Fluid Content (TFC)
Description
[1/kOhm]
Time Frame
one hour
Title
∆ Leg Fluid Shift
Description
[%] Difference between the raw data of leg fluid volume before and after tilting table.
Time Frame
one hour.
Title
∆ Total Body Water
Description
[l]
Time Frame
one hour
Title
Oxygen Saturation
Time Frame
one hour
Title
Blood Pressure (systolic, diastolic and mean)
Description
[mmHg]
Time Frame
one hour
Title
∆ Resistance (legs, body)
Description
[Ohm] electrical resistance
Time Frame
one hour
Title
∆ Reactance (legs, body)
Description
[Ohm] capacitive resitance
Time Frame
one hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bitter, MD
Organizational Affiliation
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Schindhelm Florian
Organizational Affiliation
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart - and Diabetes CenteHerz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
City
Bad Oeynhausen
State/Province
North - Rhine Westfalia
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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