Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486129
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
Myocardial Effects of NIV in OHS Patients
Sponsor:
Pavol Jozef Safarik University
Organization:
Pavol Jozef Safarik University
Study Overview
Official Title:
Long-term Myocardial Effects of Noninvasive Ventilation in Patients With Obesity Hypoventilation Syndrome
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic effects of noninvasive ventilation on myocardial function in patients with obesity hypoventilation syndrome OHS are scarcely understood The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation BiPAP on cardiac parameters and myocardial biomarkers in patients with OHS
Detailed Description:
Chronic effects of non- invasive ventilation on myocardial function in patients with obesity hypoventilation syndrome OHS are scarcely understood The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation BiPAP on cardiac parameters and myocardial biomarkers in patients with OHS Clinically stable patients with OHS referred to the tertiary centre for the initiation of long-term BiPAP therapy were consecutively enrolled in the study At baseline all participants underwent overnight cardiorespiratory polygraphy BiPAP therapy using volume-targeted spontaneoustimed mode delivered via an oro-nasal mask was initiated Beat-to-beat noninvasive monitoring by impedance cardiography was used to assess heart function at baseline and after 3 and 12 months of BiPAP use Serum troponin 1 N-Terminal Pro-B-Type Natriuretic Peptide NTProBNP tumor necrosis factor-alpha TNF-α and interleukin-6 IL-6 were monitored Potential risks and benefits comprise haemodynamic effects of NIV on cardiovascular parameters including cardiac output and stroke volume The study started 062016 and enrolment was finalized in October 2018 The study was funded by grants from the Slovak Research and Development Agency under contract No APVV-16-0158 and VEGA 1022017 and 1039322 of the Ministry of Education Slovakia The main investigator is Pavol Pobeha MD PhD co author is Ivana Paranicova MD PhD and the corresponding author study coordinator prof Ruzena Tkacova MD PhD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None