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NCT Number: NCT06486129

Myocardial Effects of NIV in OHS Patients

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive ventilation volume targetted

Procedure

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

Primary outcomes

  1. Impedance cardiography measured cardiac output

    Time frame: 12 months

    Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure

Secondary outcomes

  1. Impedance cardiography measured stroke volume

    Time frame: 12 months

    Impedance cardiography measured stroke volume before and after effective treatment of

Sponsors and collaborators

Lead sponsor

Pavol Jozef Safarik University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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