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Sleep Disordered Breathing CentralHTx-HDZ-SDB-1NCT03026634

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

An observational study of Sleep Disordered Breathing Central and Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Sleep-disordered breathing
How many people
500 participants
Where
1 siteGermany
Study dates
1 Jan 2017to 31 Dec 2020
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: End-stage heart failure patients assigned and eligible for heart transplantation

Who may be able to join

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

Who cannot join

  • heart failure patients not eligible for heart transplantation

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia, 32545

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Sleep-disordered breathing
Keywords
Sleep-Disordered Breathing, Heart Failure, Heart Transplantation
Medical subject headings
Sleep Apnea, Central, Heart Failure, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep-disordered breathingBehavioural

    Prevalence and dynamic of sleep-disordered breathing after heart transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apnea Hypopnea Index

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

    Measured: 30 days after heart transplantation

Secondary outcomes (10)

  1. Apnea Index

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

    Measured: 30 days after heart transplantation

  2. Hypopnea Index

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

    Measured: 30 days after heart transplantation

  3. Oxygen Desaturation Index

    Change in Oxygen Desaturation (ODI /h) before and after heart transplantation

    Measured: 30 days after heart transplantation

  4. Time SaO2 < 90 (%)

    Change in Time SaO2 < 90 (%) before and after heart transplantation

    Measured: 30 days after heart transplantation

  5. Respiration cycle length

    Change in Respiration cycle lengths before and after heart transplantation

    Measured: 30 days after heart transplantation

  6. Health Questionnaires

    Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)

    Measured: 30 days after heart transplantation

  7. Health Questionnaires

    ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points)

    Measured: 30 days after heart transplantation

  8. Health Questionnaires

    Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points)

    Measured: 30 days after heart transplantation

  9. Right heart catheter

    Changes in right heart catheter before and after heart transplantation

    Measured: 30 days after heart transplantation

  10. Blood gas analysis

    Changes in blood gas analyses before and after heart transplantation

    Measured: 30 days after heart transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion9 Oct 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026634
Sponsor's protocol ID
PDSAP-HTX
Acronym
HTx-HDZ-SDB-1
Status last verified
May 2021
First submitted
14 Dec 2016
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25242802

  • 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.

    PubMed 27938912

  • 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.

    PubMed 26612581

  • 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. 2026 Jun;35(3):e70256. doi: 10.1111/jsr.70256. Epub 2025 Nov 27.

    PubMed 41306066

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disordered Breathing Central and Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea Hypopnea Index (time frame: 30 days after heart transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026634, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

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