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

Heart Failure Clinical Trial

— HTx-HDZ-SDB-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026634
• Other study ID #: PDSAP-HTX
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• heart failure patients not eligible for heart transplantation

Related Conditions & MeSH terms

• Heart Failure
• Heart Transplantation
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Disordered Breathing Central

Intervention

Behavioral:
• Sleep-disordered breathing
Prevalence and dynamic of sleep-disordered breathing after heart transplantation

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia	Deutsche Herzstiftung e.V., Deutsche Stiftung für Herzforschung

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Basic K, Fox H, Spießhöfer 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. — View 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. — View 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/ehv62 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index	Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation	30 days after heart transplantation
Secondary	Apnea Index	Change in Apnea Index (AI /h) before and after heart transplantation	30 days after heart transplantation
Secondary	Hypopnea Index	Change in Hypopnea Index (HI /h) before and after heart transplantation	30 days after heart transplantation
Secondary	Oxygen Desaturation Index	Change in Oxygen Desaturation (ODI /h) before and after heart transplantation	30 days after heart transplantation
Secondary	Time SaO2 < 90 (%)	Change in Time SaO2 < 90 (%) before and after heart transplantation	30 days after heart transplantation
Secondary	Respiration cycle length	Change in Respiration cycle lengths before and after heart transplantation	30 days after heart transplantation
Secondary	Health Questionnaires	Change in MLWH questionnaire, this questionnaires obtains patient's quality of life in a score (in points)	30 days after heart transplantation
Secondary	Health Questionnaires	ESS questionnaire, this questionnaires obtains patient's sleepiness in daily life in a score (in points)	30 days after heart transplantation
Secondary	Health Questionnaires	Short Form 12 Health Survey Questionnaire, this questionnaires obtains patient's health status in a score (in points)	30 days after heart transplantation
Secondary	Right heart catheter	Changes in right heart catheter before and after heart transplantation	30 days after heart transplantation
Secondary	Blood gas analysis	Changes in blood gas analyses before and after heart transplantation	30 days after heart transplantation