Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation - a Prospective Single Center Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Disordered Breathing Central
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Apnea Hypopnea Index
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Henrik Fox, MD
Cardiologist
Heart and Diabetes Center North-Rhine Westfalia
Eligibility Criteria
Inclusion Criteria
- •End-stage heart failure patients assigned and eligible for heart transplantation
Exclusion Criteria
- •heart failure patients not eligible for heart transplantation
Outcomes
Primary Outcomes
Apnea Hypopnea Index
Time Frame: 30 days after heart transplantation
Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation
Secondary Outcomes
- Hypopnea Index(30 days after heart transplantation)
- Time SaO2 < 90 (%)(30 days after heart transplantation)
- Respiration cycle length(30 days after heart transplantation)
- Right heart catheter(30 days after heart transplantation)
- Apnea Index(30 days after heart transplantation)
- Health Questionnaires(30 days after heart transplantation)
- Oxygen Desaturation Index(30 days after heart transplantation)
- Blood gas analysis(30 days after heart transplantation)