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NCT Number: NCT03026634

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

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.

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Key information

Conditions

Sleep Disordered Breathing Central Apnea Cardiovascular Diseases Dyssomnias Heart Diseases Heart Failure Heart Transplantation Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • End-stage heart failure patients assigned and eligible for heart transplantation

Exclusion criteria

  • heart failure patients not eligible for heart transplantation

Treatment and study plan

Sleep-disordered breathing

Behavioral

Prevalence and dynamic of sleep-disordered breathing after heart transplantation

Primary outcomes

  1. Apnea Hypopnea Index

    Time frame: 30 days after heart transplantation

    Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation

Secondary outcomes

  1. Apnea Index

    Time frame: 30 days after heart transplantation

    Change in Apnea Index (AI /h) before and after heart transplantation

  2. Hypopnea Index

    Time frame: 30 days after heart transplantation

    Change in Hypopnea Index (HI /h) before and after heart transplantation

  3. Oxygen Desaturation Index

    Time frame: 30 days after heart transplantation

    Change in Oxygen Desaturation (ODI /h) before and after heart transplantation

  4. Time SaO2 < 90 (%)

    Time frame: 30 days after heart transplantation

    Change in Time SaO2 < 90 (%) before and after heart transplantation

  5. Respiration cycle length

    Time frame: 30 days after heart transplantation

    Change in Respiration cycle lengths before and after heart transplantation

  6. Health Questionnaires

    Time frame: 30 days after heart transplantation

    Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)

  7. Health Questionnaires

    Time frame: 30 days after heart transplantation

    ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points)

  8. Health Questionnaires

    Time frame: 30 days after heart transplantation

    Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points)

  9. Right heart catheter

    Time frame: 30 days after heart transplantation

    Changes in right heart catheter before and after heart transplantation

  10. Blood gas analysis

    Time frame: 30 days after heart transplantation

    Changes in blood gas analyses before and after heart transplantation

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Collaborators

  • Deutsche Stiftung für Herzforschung
  • The German Heart Foundation

Registry information

Official study title

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

Acronym: HTx-HDZ-SDB-1

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 20, 2017
Registry last updated
May 6, 2021

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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