An observational study in Sleep Disordered Breathing Central, Heart Failure and Heart Transplantation, sponsored by Heart and Diabetes Center North-Rhine Westfalia. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Heart and Diabetes Center North-Rhine Westfalia · Observational
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.
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 500 is above the median of 65 across 184 observational studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Heart and Diabetes Center North-Rhine Westfalia is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
End-stage heart failure patients assigned and eligible for heart transplantation
Exclusion Criteria:
Prevalence and dynamic of sleep-disordered breathing after heart transplantation
Apnea Hypopnea Index
Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation
Time frame: 30 days after heart transplantation
Apnea Index
Change in Apnea Index (AI /h) before and after heart transplantation
Time frame: 30 days after heart transplantation
Hypopnea Index
Change in Hypopnea Index (HI /h) before and after heart transplantation
Time frame: 30 days after heart transplantation
Oxygen Desaturation Index
Change in Oxygen Desaturation (ODI /h) before and after heart transplantation
Time frame: 30 days after heart transplantation
Time SaO2 < 90 (%)
Change in Time SaO2 \< 90 (%) before and after heart transplantation
Time frame: 30 days after heart transplantation
Respiration cycle length
Change in Respiration cycle lengths before and after heart transplantation
Time frame: 30 days after heart transplantation
Health Questionnaires
Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)
Time frame: 30 days after heart transplantation
Health Questionnaires
ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points)
Time frame: 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)
Time frame: 30 days after heart transplantation
Right heart catheter
Changes in right heart catheter before and after heart transplantation
Time frame: 30 days after heart transplantation
Blood gas analysis
Changes in blood gas analyses before and after heart transplantation
Time frame: 30 days after heart transplantation
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Heart and Diabetes Center North-Rhine Westfalia