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

Obstructive Sleep Apnoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092388
• Other study ID #: HDZNRW-KA_004_TB
• Status: Completed
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 30, 2017
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: March 2017
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnoea
• Cheyne Stokes Respiration
• Cheyne-Stokes Respiration
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

Intervention

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.
• Polysomnography/Polygraphy (PSG/PG)
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)
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
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.

Locations

Country	Name	City	State
Germany	Heart - and Diabetes CenteHerz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen	Bad Oeynhausen	North - Rhine Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac Index	[(l/min)/m²] Cardiac output from left ventricle related to body surface during tilting table	one hour
Other	? pcCO2	[mmHG] Difference of pcCO2 before and after tilting table	one hour
Other	? pcO2	[mmHG] Difference of pcO2 before and after sleep	one hour
Other	Thoracic Fluid Content (TFC)	[1/kOhm]	one hour
Other	? Leg Fluid Shift	[%] Difference between the raw data of leg fluid volume before and after tilting table.	one hour.
Other	? Total Body Water	[l]	one hour
Other	Oxygen Saturation		one hour
Other	Blood Pressure (systolic, diastolic and mean)	[mmHg]	one hour
Other	? Resistance (legs, body)	[Ohm] electrical resistance	one hour
Other	? Reactance (legs, body)	[Ohm] capacitive resitance	one hour
Primary	? Leg Fluid Shift (LFS)	[%] Difference between the raw data of leg fluid volume before and after sleep.	one night
Secondary	Apnea-Hypopnea-Index (AHI)	[/h], definition after current AASM guideline	one night
Secondary	Cheyne-Stokes-Respiration	[min] + [(%) of Total Sleep Time (TST)]	one night
Secondary	Oxygen-Desaturation-Index (ODI)	[/h], definition after current AASM guideline	one night
Secondary	Time Oxygen Saturation < 90% (TSpO2<90%)	[min] + [% (of TST)]	one night
Secondary	Oxygen Saturation (SpO2)		one night
Secondary	Sleep Efficiency		one night
Secondary	Longest Apnea time	[min]	one night
Secondary	Longest Hypopnea time	[min]	one night
Secondary	? partial pressure in capillary blood of carbon dioxide (pcCO2)	[mmHG] Difference of pcCO2 before and after sleep	one night
Secondary	? partial pressure in capillary blood of oxygen (pcO2)	[mmHG] Difference of pcO2 before and after sleep	one night
Secondary	? Resistance	[Ohm]	one night
Secondary	? Reactance	[Ohm]	one night
Secondary	? Total Body Water (TBW)	[l]	one night
Secondary	Blood Pressure (systolic, diastolic, mean)	[mmHg]	one night