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Completed

NCT Number: NCT03092388

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Bad Oeynhausen, North - Rhine Westfalia, 32545, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi Frequency Bioimpedance Analysis (mfBIA)

Diagnostic Test

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

Polysomnography/Polygraphy (PSG/PG)

Diagnostic Test

Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines.

Capillary Blood Gas Analysis (CBGA)

Diagnostic Test

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.

Tilting Table with Hemodynamic Monitoring

Diagnostic Test

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

Primary outcomes

  1. ∆ Leg Fluid Shift (LFS)

    Time frame: one night

    [%] Difference between the raw data of leg fluid volume before and after sleep.

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2017
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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