NCT03026634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

3.8 years

First QC Date

December 14, 2016

Last Update Submit

May 5, 2021

Conditions

Sleep Disordered Breathing CentralHeart FailureHeart Transplantation

Keywords

Sleep-Disordered BreathingHeart FailureHeart Transplantation

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index

    Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation

    30 days after heart transplantation

Secondary Outcomes (10)

  • Apnea Index

    30 days after heart transplantation

  • Hypopnea Index

    30 days after heart transplantation

  • Oxygen Desaturation Index

    30 days after heart transplantation

  • Time SaO2 < 90 (%)

    30 days after heart transplantation

  • Respiration cycle length

    30 days after heart transplantation

  • +5 more secondary outcomes

Interventions

Sleep-disordered breathingBEHAVIORAL

Prevalence and dynamic of sleep-disordered breathing after heart transplantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • heart failure patients not eligible for heart transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (4)

  • 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.

    PMID: 25242802RESULT

  • 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.

    PMID: 27938912RESULT

  • 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.

    PMID: 26612581RESULT

  • Potratz M, Manukyan T, Schramm R, Costard-Jackle A, Fuchs U, Morshuis M, Guenther SPW, Rojas SV, Rudolph V, Gummert JF, Fox H. Nocturnal Hypoxemic Burden Predicts Mortality in Patients Awaiting Heart Transplantation. J Sleep Res. 2025 Nov 27:e70256. doi: 10.1111/jsr.70256. Online ahead of print.

    PMID: 41306066DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum and urine samples

MeSH Terms

Conditions

Sleep Apnea, CentralHeart FailureSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

December 14, 2016

First Posted

January 20, 2017

Study Start

January 1, 2017

Primary Completion

October 9, 2020

Study Completion

December 31, 2020

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)