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Myocardial Effects of NIV in OHS Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06486129
Enrollment
13
Registered
2024-07-03
Start date
2016-03-01
Completion date
2020-01-15
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Respiratory Failure, Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Cardiac Output, stroke volume

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)

Interventions

PROCEDURENoninvasive 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

Sponsors

Pavol Jozef Safarik University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impedance cardiography measured cardiac output12 monthsImpedance cardiography measured cardiac output before and after effective treatment of respiratory failure

Secondary

MeasureTime frameDescription
Impedance cardiography measured stroke volume12 monthsImpedance cardiography measured stroke volume before and after effective treatment of

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026