Pulmonary Vascular Resistance AbnormalityNCT05484596
PV Loop and Pulmonary Hypertension
An observational study of Pulmonary Vascular Resistance Abnormality, run by Hythem Nawaytou at 2 sites in United States.
Trial summary
The right ventricular (RV) systolic function is a key determinant of outcome in patients with pulmonary hypertension and elevated pulmonary vascular resistance. As the pulmonary artery pressure and vascular resistance increase (i.e. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Pulmonary Vascular Resistance Abnormality
- What is being tested?
- Measuring VA Coupling
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2020to 30 Apr 2025
- Phase
- Observational
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Elevated Pulmonary Arterial Hypertension
Who may be able to join
- Children 1-21 years of age
- Patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension
- Structurally normal heart
Who cannot join
- Pulmonary hypertension secondary to pulmonary venous hypertension defined as pulmonary capillary wedge pressure of more than or equal to 15mmHg
- Pulmonary hypertension secondary to mixed pulmonary arterial and venous hypertension
- Patient will be excluded from performing an MRI if they have:
- claustrophobia, metal implants or allergy to contrast
- Patients will be excluded from performing a cardiopulmonary exercise test (CPET) if they are: 1) less than 8 years or 2) unable to follow instructions to run on a treadmill.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Brittany Faanes, MPH, CCRP, 612-625-5929, grego318@umn.edu
Gurumurthy Hiremath, MD
- Recruiting
Pediatric Pulmonary Hypertension Program
San Francisco, California, 94143
Jasmine Becerra, BS, 415-476-2649, jasmine.becerra@ucsf.edu
Hythem Nawaytou, MD
About this study
Official title: Non-Invasive Evaluation of Right Ventricular - Pulmonary Arterial Coupling in Children With Elevated Pulmonary Vascular Resistance
The right ventricular (RV) systolic function is a key determinant of outcome in patients with pulmonary hypertension and elevated pulmonary vascular resistance. As the pulmonary artery pressure and vascular resistance increase (i.e. RV afterload) in these patients, so does the right ventricular contractility in an attempt to maintain cardiac output. This is response of a ventricle to its afterload is termed ventriculo-arterial (VA) coupling. However, there is a limit to this increase in contractility after which VA uncoupling occurs ultimately leading to decrease cardiac output and right ventricular failure. The accepted gold standard for measurement of VA coupling is the ratio of the end systolic ventricular elastance (Ees) to the end systolic arterial elastance (Ea) measured invasively via high fidelity conductance catheters during cardiac catheterization. In this study, the aim is to devise a non-invasive scoring system that can identify VA uncoupling in patients with elevated pulmonary vascular resistance using echocardiography, cardiac MRI, cardiopulmonary exercise testing and brain natriuretic peptide levels. The hypothesis is that a group of morphologic and functional variables obtained noninvasively can differentiate an RV with VA coupling from that with VA uncoupling.
- Being tested
- Measuring VA Coupling
- Keywords
- pulmonary vascular resistance, pediatric, VA uncoupling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring VA CouplingProcedure or surgery
Subjects will undergo clinically indicated investigations and tests. The research part of the study is measuring the VA coupling using high fidelity catheters. That is expected to increase the duration of the cardiac catheterization for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | Subjects will undergo clinically indicated investigations and tests. The research part of the study is measuring the VA coupling using high fidelity catheters. That is expected to increase the duration of the cardiac catheterization for 30 minutes. Receives: Procedure: Measuring VA Coupling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify echocardiographic measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling
Yes/No result: Can echocardiographic measurements allow non-invasive identification of VA uncoupling (defined as Ees/Ea <0.805). Three ratios: tricuspid annular plane systolic excursion to the pulmonary artery acceleration time, right ventricular free wall strain to the pulmonary artery acceleration time and, right ventricular fractional area change to the pulmonary artery acceleration time.
Measured: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Identify cMRI measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling.
Yes/No result: Can cMRI measurements allow non-invasive identification of VA uncoupling (defined as Ees/Ea <0.805). Two ratios: right ventricular ejection fraction to right ventricular end systolic volume and right ventricular ejection fraction to pulmonary artery acceleration time (by echocardiography).
Measured: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Identify 6-minute walk distance cutoff that can identify VA uncoupling
Yes/No: Can 6-minute walk distance identify VA uncoupling (defined as Ees/Es<0.805)
Measured: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Identify brain natriuretic peptide cutoff value that can identify VA uncoupling
Yes/No: Can brain natriuretic peptide identify VA uncoupling (defined as Ees/Es<0.805)
Measured: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start27 Apr 2020
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Vascular Resistance AbnormalityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hythem Nawaytou
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor-investigator, Hythem Nawaytou, University of California, San Francisco
- Investigators
- Gurumurthy Hiremath, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484596
- Sponsor's protocol ID
- PEDS-2020-29351
- Status last verified
- Sep 2023
- First submitted
- 8 Jul 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Evaluation of Right Ventricular - Pulmonary Arterial Coupling in Children With Elevated Pulmonary Vascular Resistance
- ClinicalTrials.gov ID
- NCT05484596
- Acronym / sponsor ID
- PEDS-2020-29351
- Keywords
- pulmonary vascular resistance, pediatric, VA uncoupling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Hythem NawaytouUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 2 Aug 2022 (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.
The right ventricular (RV) systolic function is a key determinant of outcome in patients with pulmonary hypertension and elevated pulmonary vascular resistance. As the pulmonary artery pressure and vascular resistance increase (i.e. RV afterload) in these patients, so does the right ventricular contractility in an attempt to maintain cardiac output. This is response of a ventricle to its afterload is termed ventriculo-arterial (VA) coupling. However, there is a limit to this increase in contractility after which VA uncoupling occurs ultimately leading to decrease cardiac output and right ventricular failure. The accepted gold standard for measurement of VA coupling is the ratio of the end systolic ventricular elastance (Ees) to the end systolic arterial elastance (Ea) measured invasively via high fidelity conductance catheters during cardiac catheterization. In this study, the aim is to devise a non-invasive scoring system that can identify VA uncoupling in patients with elevated pulmonary vascular resistance using echocardiography, cardiac MRI, cardiopulmonary exercise testing and brain natriuretic peptide levels. The hypothesis is that a group of morphologic and functional variables obtained noninvasively can differentiate an RV with VA coupling from that with VA uncoupling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Procedure: Measuring VA CouplingSubjects will undergo clinically indicated investigations and tests. The research part of the study is measuring the VA coupling using high fidelity catheters. That is expected to increase the duration of the cardiac catheterization for 30 minutes. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Elevated Pulmonary Arterial Hypertension
Key inclusion criteria (3 listed)
- Children 1-21 years of age
- Patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension
- Structurally normal heart
Key exclusion criteria (5 listed)
- Pulmonary hypertension secondary to pulmonary venous hypertension defined as pulmonary capillary wedge pressure of more than or equal to 15mmHg
- Pulmonary hypertension secondary to mixed pulmonary arterial and venous hypertension
- Patient will be excluded from performing an MRI if they have:
- claustrophobia, metal implants or allergy to contrast
- Patients will be excluded from performing a cardiopulmonary exercise test (CPET) if they are: 1) less than 8 years or 2) unable to follow instructions to run on a treadmill.
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 |
|---|---|---|
| Measuring VA CouplingSubjects will undergo clinically indicated investigations and tests. The research part of the study is measuring the VA coupling using high fidelity catheters. That is expected to increase the duration of the cardiac catheterization for 30 minutes. | Procedure or surgery | Observational Group |
Primary outcome
Identify echocardiographic measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling
Time frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Yes/No result: Can echocardiographic measurements allow non-invasive identification of VA uncoupling (defined as Ees/Ea <0.805). Three ratios: tricuspid annular plane systolic excursion to the pulmonary artery acceleration time, right ventricular free wall strain to the pulmonary artery acceleration time and, right ventricular fractional area change to the pulmonary artery acceleration time.
Identify cMRI measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling.
Time frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Yes/No result: Can cMRI measurements allow non-invasive identification of VA uncoupling (defined as Ees/Ea <0.805). Two ratios: right ventricular ejection fraction to right ventricular end systolic volume and right ventricular ejection fraction to pulmonary artery acceleration time (by echocardiography).
Identify 6-minute walk distance cutoff that can identify VA uncoupling
Time frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Yes/No: Can 6-minute walk distance identify VA uncoupling (defined as Ees/Es<0.805)
Identify brain natriuretic peptide cutoff value that can identify VA uncoupling
Time frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization
Yes/No: Can brain natriuretic peptide identify VA uncoupling (defined as Ees/Es<0.805)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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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.
Gurumurthy Hiremath, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Vascular Resistance Abnormality, run by Hythem Nawaytou at 2 sites 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brittany Faanes, MPH, CCRP (612-625-5929, grego318@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify echocardiographic measurements of right ventricular systolic function and pulmonary blood flow and their cutoff values contemporaneous that can identify VA uncoupling (time frame: within one week of measurement of ventriculo-arterial coupling ratio during cardiac catheterization). The study lists 4 primary outcomes in all. 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 26 Sep 2023.