Clinical trial NCT06486129: Myocardial Effects of NIV in OHS Patients
Official title: Long-term Myocardial Effects of Noninvasive Ventilation in Patients With Obesity Hypoventilation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure Chronic
Obesity Hypoventilation Syndrome
Obstructive Sleep Apnea
Cardiac Output, Low
Keywords: Respiratory Failure
Obesity Hypoventilation Syndrome
Obstructive Sleep Apnea
Cardiac Output
stroke volume
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 13
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Impedance cardiography measured cardiac output
timeFrame: 12 months
Secondary outcomes:
measure: Impedance cardiography measured stroke volume
timeFrame: 12 months
Other outcomes:
Locations:
city: Košice 4
country: Slovakia
facility: Department of respiratory medicine and tuberculosis, Pavol Jozef Safarik University, Medical Faculty and L. Pasteur University Hospital In Kosice
Study officials:
References:
citation: Pobeha P, Paranicova I, Trojova I, Tkacova R, Joppa P. Acute hemodynamic effects of non-invasive ventilation in patients with obesity hypoventilation syndrome. Bratisl Lek Listy. 2021;122(4):248-250. doi: 10.4149/BLL_2021_040.