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

NCT03092388 | Completed

• 1 other identifier: HDZNRW-KA_004_TB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnoea; Central Sleep Apnoea; Cheyne Stokes Respiration

Keywords

Sleep-Disordered Breathing; Heart Failure; Leg Fluid Shift

Outcome Measures

Primary Outcomes (1)

• ∆ Leg Fluid Shift (LFS)

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

  one night

Secondary Outcomes (14)

• Apnea-Hypopnea-Index (AHI)

  one night

• Cheyne-Stokes-Respiration

  one night

• Oxygen-Desaturation-Index (ODI)

  one night

• Time Oxygen Saturation < 90% (TSpO2<90%)

  one night

• Oxygen Saturation (SpO2)

  one night

Other Outcomes (10)

• Cardiac Index

  one hour

• ∆ pcCO2

  one hour

• ∆ pcO2

  one hour

Study Arms (2)

Study Group Basic

EXPERIMENTAL

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); Diagnostic Test: Polysomnography/Polygraphy (PSG/PG); Diagnostic Test: Capillary Blood Gas Analysis (CBGA)

Study Group Extended

EXPERIMENTAL

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); Diagnostic Test: Polysomnography/Polygraphy (PSG/PG); Diagnostic Test: Capillary Blood Gas Analysis (CBGA); Diagnostic Test: Tilting Table with Hemodynamic Monitoring

Interventions

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.

Also known as: Nutriguard M, Data Input, Darmstadt, Germany

Study Group Basic; Study Group Extended

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.

Study Group Basic; Study Group Extended

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.

Study Group Basic; Study Group Extended

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.

Also known as: Task Force Monitor, CNsystems, Vienna, Austria

Study Group Extended

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Heart Failure
• reduced left ventricular ejection fraction (LVEF) ≤ 45%
• NYHA I - IV

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

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

Bad Oeynhausen, North - Rhine Westfalia, 32545, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central; Cheyne-Stokes Respiration; Sleep Apnea Syndromes; Heart Failure

Interventions

Polysomnography; Hemodynamic Monitoring

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Thomas Bitter, MD

  Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

  STUDY DIRECTOR

• Schindhelm Florian

  Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)