Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation

Study Overview
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Brief Summary
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Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation.

Detailed Description
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Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation, as this topic is hardly studied yet and previous reports suggest changes in the entity of sleep-disordered breathing through heart transplantation. The circumstances and the impact of sleep-disordered breathing or residuals in heart transplant patients is not well understood yet and will be subject of this study.

Official Title
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Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation - a Prospective Single Center Trial

Conditions
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Sleep Disordered Breathing Central, Heart Failure, Heart Transplantation

Intervention / Treatment
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* Behavioral: Sleep-disordered breathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End-stage heart failure patients assigned and eligible for heart transplantation Exclusion Criteria: heart failure patients not eligible for heart transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Sleep-disordered breathing|Prevalence and dynamic of sleep-disordered breathing after heart transplantation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index | Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation | 30 days after heart transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Index | Change in Apnea Index (AI /h) before and after heart transplantation | 30 days after heart transplantation | 
| Hypopnea Index | Change in Hypopnea Index (HI /h) before and after heart transplantation | 30 days after heart transplantation | 
| Oxygen Desaturation Index | Change in Oxygen Desaturation (ODI /h) before and after heart transplantation | 30 days after heart transplantation | 
| Time SaO2 < 90 (%) | Change in Time SaO2 < 90 (%) before and after heart transplantation | 30 days after heart transplantation | 
| Respiration cycle length | Change in Respiration cycle lengths before and after heart transplantation | 30 days after heart transplantation | 
| Health Questionnaires | Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points) | 30 days after heart transplantation | 
| Health Questionnaires | ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points) | 30 days after heart transplantation | 
| Health Questionnaires | Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points) | 30 days after heart transplantation | 
| Right heart catheter | Changes in right heart catheter before and after heart transplantation | 30 days after heart transplantation | 
| Blood gas analysis | Changes in blood gas analyses before and after heart transplantation | 30 days after heart transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep-Disordered Breathing, Heart Failure, Heart Transplantation