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

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).

Conditions

• Obstructive Sleep Apnoea
• Central Sleep Apnoea
• Cheyne Stokes Respiration

Interventions

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.

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.

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia

  lead OTHER

Principal Investigators

• Thomas Bitter, MD · Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

• Schindhelm Florian · Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Germany

Study Locations