Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation (HTx-HDZ-SDB-1)

May 5, 2021 updated by: Henrik Fox, MD, Heart and Diabetes Center North-Rhine Westfalia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bad Oeynhausen, NRW, Germany, 32545
        • Herz- und Diabeteszentrum NRW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • heart failure patients not eligible for heart transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index
Time Frame: 30 days after heart transplantation
Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation
30 days after heart transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Index
Time Frame: 30 days after heart transplantation
Change in Apnea Index (AI /h) before and after heart transplantation
30 days after heart transplantation
Hypopnea Index
Time Frame: 30 days after heart transplantation
Change in Hypopnea Index (HI /h) before and after heart transplantation
30 days after heart transplantation
Oxygen Desaturation Index
Time Frame: 30 days after heart transplantation
Change in Oxygen Desaturation (ODI /h) before and after heart transplantation
30 days after heart transplantation
Time SaO2 < 90 (%)
Time Frame: 30 days after heart transplantation
Change in Time SaO2 < 90 (%) before and after heart transplantation
30 days after heart transplantation
Respiration cycle length
Time Frame: 30 days after heart transplantation
Change in Respiration cycle lengths before and after heart transplantation
30 days after heart transplantation
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)
30 days after heart transplantation
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)
30 days after heart transplantation
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)
30 days after heart transplantation
Right heart catheter
Time Frame: 30 days after heart transplantation
Changes in right heart catheter before and after heart transplantation
30 days after heart transplantation
Blood gas analysis
Time Frame: 30 days after heart transplantation
Changes in blood gas analyses before and after heart transplantation
30 days after heart transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Collaborators

Deutsche Stiftung für Herzforschung
Deutsche Herzstiftung e.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

October 9, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDSAP-HTX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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