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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03026634
Acronym
HTx-HDZ-SDB-1
Enrollment
500
Registered
2017-01-20
Start date
2017-01-01
Completion date
2020-12-31
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Heart Transplantation, Sleep Disordered Breathing Central

Keywords

Sleep-Disordered Breathing, Heart Failure, Heart Transplantation

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.

Interventions

BEHAVIORALSleep-disordered breathing

Prevalence and dynamic of sleep-disordered breathing after heart transplantation

Sponsors

The German Heart Foundation
CollaboratorOTHER
Deutsche Stiftung für Herzforschung
CollaboratorOTHER
Heart and Diabetes Center North-Rhine Westfalia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* heart failure patients not eligible for heart transplantation

Design outcomes

Primary

MeasureTime frameDescription
Apnea Hypopnea Index30 days after heart transplantationChange in Apnea Hypopnea Index (AHI /h) before and after heart transplantation

Secondary

MeasureTime frameDescription
Hypopnea Index30 days after heart transplantationChange in Hypopnea Index (HI /h) before and after heart transplantation
Oxygen Desaturation Index30 days after heart transplantationChange in Oxygen Desaturation (ODI /h) before and after heart transplantation
Time SaO2 < 90 (%)30 days after heart transplantationChange in Time SaO2 \< 90 (%) before and after heart transplantation
Apnea Index30 days after heart transplantationChange in Apnea Index (AI /h) before and after heart transplantation
Health Questionnaires30 days after heart transplantationChange in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)
Right heart catheter30 days after heart transplantationChanges in right heart catheter before and after heart transplantation
Blood gas analysis30 days after heart transplantationChanges in blood gas analyses before and after heart transplantation
Respiration cycle length30 days after heart transplantationChange in Respiration cycle lengths before and after heart transplantation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026