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

Completed

• Conditions: Sleep Disordered Breathing Central; Heart Failure; Heart Transplantation

• Registration Number: NCT03026634
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

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.

Study Timeline

• Study First Submitted: 2016-12-14
• Study Start: 2017-01-01
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Primary Completion: 2020-10-09
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• heart failure patients not eligible for heart transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	30 days after heart transplantation	Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation

Secondary Outcome Measures

Name	Time	Method
Hypopnea Index	30 days after heart transplantation	Change in Hypopnea Index (HI /h) before and after heart transplantation
Time SaO2 < 90 (%)	30 days after heart transplantation	Change in Time SaO2 \< 90 (%) before and after heart transplantation
Respiration cycle length	30 days after heart transplantation	Change in Respiration cycle lengths before and after heart transplantation
Right heart catheter	30 days after heart transplantation	Changes in right heart catheter before and after heart transplantation
Apnea Index	30 days after heart transplantation	Change in Apnea Index (AI /h) before and after heart transplantation
Health Questionnaires	30 days after heart transplantation	Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points)
Oxygen Desaturation Index	30 days after heart transplantation	Change in Oxygen Desaturation (ODI /h) before and after heart transplantation
Blood gas analysis	30 days after heart transplantation	Changes in blood gas analyses before and after heart transplantation

Trial Locations

Locations (1)

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, NRW, Germany