Respiratory Failure ChronicNCT06486129
Myocardial Effects of NIV in OHS Patients
A study testing Noninvasive ventilation volume targetted in people with Respiratory Failure Chronic and Obesity Hypoventilation Syndrome, run by Pavol Jozef Safarik University at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Respiratory Failure Chronic, Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea
- What is being tested?
- Noninvasive ventilation volume targetted
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Mar 2016to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable patients with OHS and chronic severe hypercapnia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Slovakia1 site
Department of respiratory medicine and tuberculosis, Pavol Jozef Safarik University, Medical Faculty and L. Pasteur University Hospital In Kosice
Košice, 04190
About this study
Official title: 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.
Read the 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)
- Conditions
- Respiratory Failure Chronic, Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Cardiac Output, Low
- Being tested
- Noninvasive ventilation volume targetted
- Keywords
- Respiratory Failure, Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Cardiac Output, stroke volume
- Medical subject headings
- Obesity Hypoventilation Syndrome, Sleep Apnea, Obstructive, Cardiac Output, Low, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilation volume targettedProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy | Experimental | 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 Receives: Procedure: Noninvasive ventilation volume targetted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impedance cardiography measured cardiac output
Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure
Measured: 12 months
Secondary outcomes (1)
Impedance cardiography measured stroke volume
Impedance cardiography measured stroke volume before and after effective treatment of
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2016
- Primary completion15 Nov 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pavol Jozef Safarik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavol Pobeha, Pavol Jozef Safarik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486129
- Sponsor's protocol ID
- VEGA 1/0220/17
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request
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.
PubMed 33729816
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Myocardial Effects of Noninvasive Ventilation in Patients With Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT06486129
- Acronym / sponsor ID
- VEGA 1/0220/17
- Conditions
- Respiratory Failure Chronic, Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Cardiac Output, Low
- Keywords
- Respiratory Failure, Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Cardiac Output, stroke volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Pavol Jozef Safarik UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy | Experimental | Procedure: Noninvasive ventilation volume targettedClinically 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 |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically stable patients with OHS and chronic severe hypercapnia
Key exclusion criteria (7 listed)
- inability to provide written informed consent
- neuromuscular diseases
- chest wall diseases
- metabolic diseases
- acute respiratory tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive ventilation volume targettedhe 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 | Procedure or surgery | Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy |
Primary outcome
Impedance cardiography measured cardiac output
Time frame: 12 months
Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure
1 secondary outcome
Impedance cardiography measured stroke volume
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 33729816Pobeha 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.
- Individual participant dataSharing planned: Undecided. On request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation volume targetted in people with Respiratory Failure Chronic and Obesity Hypoventilation Syndrome, run by Pavol Jozef Safarik University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impedance cardiography measured cardiac output (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06486129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.