Clinical trial NCT03026634: Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation
Official title: Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation - a Prospective Single Center Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disordered Breathing Central
Heart Failure
Heart Transplantation
Keywords: Sleep-Disordered Breathing
Heart Failure
Heart Transplantation
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
Collaborators: name: The German Heart Foundation
name: Deutsche Stiftung für Herzforschung
First posted: 2017-01-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: End-stage heart failure patients assigned and eligible for 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* heart failure patients not eligible for heart transplantation

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 30 days after heart transplantation
Secondary outcomes:
measure: Apnea Index
timeFrame: 30 days after heart transplantation
measure: Hypopnea Index
timeFrame: 30 days after heart transplantation
measure: Oxygen Desaturation Index
timeFrame: 30 days after heart transplantation
measure: Time SaO2 < 90 (%)
timeFrame: 30 days after heart transplantation
measure: Respiration cycle length
timeFrame: 30 days after heart transplantation
measure: Health Questionnaires
timeFrame: 30 days after heart transplantation
measure: Health Questionnaires
timeFrame: 30 days after heart transplantation
measure: Health Questionnaires
timeFrame: 30 days after heart transplantation
measure: Right heart catheter
timeFrame: 30 days after heart transplantation
measure: Blood gas analysis
timeFrame: 30 days after heart transplantation
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
state: NRW
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.