Single-ventricleNCT05634226
Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
A study testing Hands-free oral-positive pressure device (oPEP) in people with Single-ventricle, run by Tarek Alsaied at 1 site in United States.
Trial summary
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Single-ventricle
- What is being tested?
- Hands-free oral-positive pressure device (oPEP)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with single ventricle with Fontan palliation
- Over the age of 8 years who would be cooperative with breathing through the oPEP device
Who cannot join
- Patients with Fontan palliation under the age of 8 years
- Patients who have interrupted inferior vena cava
- Patients with abnormal pulmonary artery anatomy
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital Pittsburgh
Pittsburgh, Pennsylvania, 15235
About this study
Official title: Oral Positive Pressure Device (oPEP) Effect on Flow Pulsatility in the Fontan Circuit
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. The investigators will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, the investigators will have patients use the device after their clinical echocardiogram for their clinic appointment. The investigators will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.
Read the detailed description
The aortic VTI secondary outcome was inadvertently left out of the initial registration and is now reported
- Conditions
- Single-ventricle
- Being tested
- Hands-free oral-positive pressure device (oPEP)
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-free oral-positive pressure device (oPEP)Device
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. We will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, we will have patients use the device after their clinical echocardiogram for their clinic appointment. We will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.
| Study group | Role | What they receive |
|---|---|---|
| Hands-free oral-positive pressure device (oPEP) | Experimental | Not described Receives: Device: Hands-free oral-positive pressure device (oPEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Pulsatility Index
This will be measured by echocardiogram using Doppler evaluation of the pulmonary artery
The Pulmonary Artery Pulsatility Index (PAPI) is calculated using Doppler-derived pulmonary artery velocities:
PAPI= (Systolic Velocity - Diastolic Velocity) /Mean Velocity
Measured: The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device
Secondary outcomes (1)
Aortic Valve VTI
This was measured by echocardiography
Aortic Valve Velocity Time Integral (VTI) Definition: Aortic VTI is a key echocardiographic measurement reflecting stroke distance and cardiac output.
Measurement:
Obtained using pulsed-wave Doppler at the left ventricular outflow tract (LVOT) just below the aortic valve.
The VTI is measured by tracing the Doppler envelope of the LVOT flow during systole.
Clinical Importance:
Stroke Volume Calculation:
Stroke Volume = LVOT VTI × LVOT Area
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Aug 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Single-ventricleStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarek Alsaied
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarek Alsaied, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634226
- Sponsor's protocol ID
- STUDY22050151
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2022
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Positive Pressure Device (oPEP) Effect on Flow Pulsatility in the Fontan Circuit
- ClinicalTrials.gov ID
- NCT05634226
- Acronym / sponsor ID
- STUDY22050151
- Conditions
- Single-ventricle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tarek AlsaiedUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. The investigators will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, the investigators will have patients use the device after their clinical echocardiogram for their clinic appointment. The investigators will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.
Detailed description
The aortic VTI secondary outcome was inadvertently left out of the initial registration and is now reported
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hands-free oral-positive pressure device (oPEP) | Experimental | Device: Hands-free oral-positive pressure device (oPEP) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with single ventricle with Fontan palliation
- Over the age of 8 years who would be cooperative with breathing through the oPEP device
Key exclusion criteria (3 listed)
- Patients with Fontan palliation under the age of 8 years
- Patients who have interrupted inferior vena cava
- Patients with abnormal pulmonary artery anatomy
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 |
|---|---|---|
| Hands-free oral-positive pressure device (oPEP)This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. We will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, we will have patients use the device after their clinical echocardiogram for their clinic appointment. We will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements. | Device | Hands-free oral-positive pressure device (oPEP) |
Primary outcome
Change in Pulmonary Pulsatility Index
Time frame: The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device
This will be measured by echocardiogram using Doppler evaluation of the pulmonary artery The Pulmonary Artery Pulsatility Index (PAPI) is calculated using Doppler-derived pulmonary artery velocities: PAPI= (Systolic Velocity - Diastolic Velocity) /Mean Velocity
1 secondary outcome
Aortic Valve VTI
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Single-ventricle
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
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 Hands-free oral-positive pressure device (oPEP) in people with Single-ventricle, run by Tarek Alsaied at 1 site in United States.
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 2 inclusion and 3 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 10 Feb 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pulmonary Pulsatility Index (time frame: The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.