Myocardial Effects of NIV in OHS Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome; Cardiac Output, Low; Respiratory Failure Chronic
• Intervention / Treatment: Procedure: Noninvasive ventilation volume targetted

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Košice 4, Slovakia, 04190
    • Department of respiratory medicine and tuberculosis, Pavol Jozef Safarik University, Medical Faculty and L. Pasteur University Hospital In Kosice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy; 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	Procedure: Noninvasive 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impedance cardiography measured cardiac output	Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impedance cardiography measured stroke volume	Impedance cardiography measured stroke volume before and after effective treatment of	12 months

Collaborators and Investigators

• Sponsor: Pavol Jozef Safarik University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Respiratory Failure; Cardiac Output; stroke volume; Obesity Hypoventilation Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Obesity; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Cardiac Output, Low
• Other Study ID Numbers: VEGA 1/0220/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: On request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No