HTx-HDZ-SDB-1: Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03026634
• Collaborator: Deutsche Herzstiftung e.V. (Other), Deutsche Stiftung für Herzforschung (Other)
• Enrollment: 500
• Location: 1
• Actual Duration (Months): 48
• Patients Per Site Per Month: 10.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disordered Breathing Central; Heart Failure; Heart Transplantation	Behavioral: Sleep-disordered breathing

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation - a Prospective Single Center Trial
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Oct 9, 2020
• Actual Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Apnea Hypopnea Index [30 days after heart transplantation]

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

Secondary Outcome Measures

1. Apnea Index [30 days after heart transplantation]

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

2. Hypopnea Index [30 days after heart transplantation]

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

3. Oxygen Desaturation Index [30 days after heart transplantation]

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

4. Time SaO2 < 90 (%) [30 days after heart transplantation]

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

5. Respiration cycle length [30 days after heart transplantation]

   Change in Respiration cycle lengths before and after heart transplantation

6. Health Questionnaires [30 days after heart transplantation]

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

7. Health Questionnaires [30 days after heart transplantation]

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

8. Health Questionnaires [30 days after heart transplantation]

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

9. Right heart catheter [30 days after heart transplantation]

   Changes in right heart catheter before and after heart transplantation

10. Blood gas analysis [30 days after heart transplantation]

    Changes in blood gas analyses before and after heart transplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• heart failure patients not eligible for heart transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	NRW	Germany	32545

Sponsors and Collaborators

• Heart and Diabetes Center North-Rhine Westfalia
• Deutsche Herzstiftung e.V.
• Deutsche Stiftung für Herzforschung

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henrik Fox, MD, Cardiologist, Heart and Diabetes Center North-Rhine Westfalia
• ClinicalTrials.gov Identifier: NCT03026634
• Other Study ID Numbers: PDSAP-HTX
• First Posted: Jan 20, 2017
• Last Update Posted: May 6, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Henrik Fox, MD, Cardiologist, Heart and Diabetes Center North-Rhine Westfalia: Sleep-Disordered Breathing; Heart Failure; Heart Transplantation
• Additional relevant MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Heart Failure

Study Results

No Results Posted as of May 6, 2021