NCT06486129

Myocardial Effects of NIV in OHS Patients

Long-term Myocardial Effects of Noninvasive Ventilation in Patients With Obesity Hypoventilation Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pavol Jozef Safarik University · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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 spontaneous/timed 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 06/2016 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 1/0220/17 and 1/0393/22 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)

Conditions

• Respiratory Failure Chronic
• Obesity Hypoventilation Syndrome
• Obstructive Sleep Apnea
• Cardiac Output, Low

Interventions

Type	Name	Description
PROCEDURE	Noninvasive ventilation volume targetted	he 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

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-11-15
• Completion: 2020-01-15
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: Slovakia