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

NCT ID: NCT03026634

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Disordered Breathing Central Heart Failure Heart Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Sleep-disordered breathing

Prevalence and dynamic of sleep-disordered breathing after heart transplantation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* heart failure patients not eligible for heart transplantation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The German Heart Foundation

OTHER

Sponsor Role collaborator

Deutsche Stiftung für Herzforschung

OTHER

Sponsor Role collaborator

Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Henrik Fox, MD

Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed.2014.06.063.

Reference Type RESULT
PMID: 25242802 (View on PubMed)

Basic K, Fox H, Spiesshofer J, Bitter T, Horstkotte D, Oldenburg O. Improvements of central respiratory events, Cheyne-Stokes respiration and oxygenation in patients hospitalized for acute decompensated heart failure. Sleep Med. 2016 Nov-Dec;27-28:15-19. doi: 10.1016/j.sleep.2016.10.006. Epub 2016 Oct 28.

Reference Type RESULT
PMID: 27938912 (View on PubMed)

Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, Horstkotte D, Wegscheider K. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016 Jun 1;37(21):1695-703. doi: 10.1093/eurheartj/ehv624. Epub 2015 Nov 26.

Reference Type RESULT
PMID: 26612581 (View on PubMed)

Other Identifiers

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PDSAP-HTX

Identifier Type: -

Identifier Source: org_study_id

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