Myocardial Effects of NIV in OHS Patients

Pavol Jozef Safarik University

Status: Completed

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

Treatments: Procedure: Noninvasive ventilation volume targetted

Study type: Interventional

Funder types: Other

Identifiers

NCT06486129

VEGA 1/0220/17

Details and patient eligibility

About

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.

Full 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)

Enrollment: 13 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy

Experimental group

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

Treatment:

Procedure: Noninvasive ventilation volume targetted