Myocardial Effects of NIV in OHS Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2020-01-15

Brief Summary

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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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Detailed Description

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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)

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Noninvasive ventilation volume targetted

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No