Myocardial Effects of NIV in OHS Patients

Not Applicable

Completed

• Conditions: Respiratory Failure Chronic; Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome; Cardiac Output, Low
• Interventions: Procedure: Noninvasive ventilation volume targetted

• Registration Number: NCT06486129
• Lead Sponsor: Pavol Jozef Safarik University

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 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)

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2019-11-15
• Study Completion: 2020-01-15
• Status Verified: 2024-06
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Clinically stable patients with OHS and chronic severe hypercapnia

Exclusion Criteria

• inability to provide written informed consent
• neuromuscular diseases
• chest wall diseases
• metabolic diseases
• acute respiratory tract infection
• chronic obstructive pulmonary disease (COPD)
• systolic LV failure as evidenced by LV ejection fraction<45% on echocardiography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy	Noninvasive ventilation volume targetted	Clinically stable patients with OHS and severe hypercapnia during the daytime, referred to the tertiary clinic for the initiation of long-term NIV to alleviate chronic respiratory failure were consecutively enrolled to the study

Primary Outcome Measures

Name	Time	Method
Impedance cardiography measured cardiac output	12 months	Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure

Secondary Outcome Measures

Name	Time	Method
Impedance cardiography measured stroke volume	12 months	Impedance cardiography measured stroke volume before and after effective treatment of

Trial Locations

Locations (1)

Department of respiratory medicine and tuberculosis, Pavol Jozef Safarik University, Medical Faculty and L. Pasteur University Hospital In Kosice; 🇸🇰 Košice 4, Slovakia