Pulmonary HypertensionNCT03564522
Image-based Multi-scale Modeling Framework of the Cardiopulmonary System: Longitudinal Calibration and Assessment of Therapies in Pediatric Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Congenital Heart Disease, run by University of Michigan at 2 sites in United States.
Trial summary
This study looks to develop a multi-scale computational model of Pulmonary Hypertension, this clinical model will be calibrated using longitudinal, retrospectively and prospectively acquired human clinical data. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Pulmonary Hypertension, Congenital Heart Disease, Pediatric Congenital Heart Disease
- What is being tested?
- cardiac catheterization and Cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2017to 28 Jul 2023
- 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 6 to 25 years
- All sexes
- Child, Adult
Study population: Pulmonary hypertension patients will be defined by a mean artery blood pressure >25 mmHg. Transplant patients are tested for pulmonary vascular resistance prior to transplant; if it is too high, transplant is contraindicated. So this group comprises patients who have normal right ventricular function and pulmonary vascular function to act as a control for the right-sided disease that we are testing, and in addition regularly undergo cardiac catheterization for clinical purposes.
Who may be able to join
- Patients has been clinically diagnosed with pulmonary hypertension (>25 mmHg) or patient is a biopsy-proven non-rejecting cardiac transplant recipient
- Receiving partial or full care from pediatric cardiology team at Mott Children's Hospital (may have a primary cardiologist elsewhere).
Who cannot join
- Girls and women who are pregnant or actively trying to become pregnant
- Patients with significant neurocognitive impairment that precludes their ability to sign a consent form
- Patient has a contraindication to right-heart catheterization (RHC) examination, which includes patients with hypoxia and those who have difficulty maintaining supine position for the procedure.
- Patients with the following genetic syndromes:Trisomy 21 if unable to assent or consent, Trisomy 18,Trisomy 13, Other genetic syndromes at the discretion of the Primary Investigator
- Patients with unrepaired single ventricles (i.e., Pre-Fontan physiology)
- Patients who have heart failure and are deemed to be high risk to undergo tests that require sedation/anesthesia.
- Patients who require IV sedation or general anesthesia for research only MRI
- Patients with a pacemaker/internal defibrillator will be excluded from MRI PORTION ONLY
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mott Children's Hospital University of Michigan
Ann Arbor, Michigan, 48109
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This study looks to develop a multi-scale computational model of Pulmonary Hypertension, this clinical model will be calibrated using longitudinal, retrospectively and prospectively acquired human clinical data.
Read the detailed description
Pulmonary hypertension (PH) is a complex disorder associated with elevated pulmonary arterial pressure. Unlike systemic hypertension, PH is difficult to detect in routine physical examinations and the current gold standard for diagnosing PH is through invasive right heart catheterization. Prolonged PH results in functional, structural and anatomical changes in the right ventricle (RV), large pulmonary arteries, and the pulmonary micro-circulation that ultimately lead to decompensated RV failure and death. Unlike in systemic hypertension, for which patients have effective pharmacological management of blood pressure for decades, PH prognosis remains poor with 15% mortality within 1 year on modern therapy. Our current understanding of PH has largely been obtained through animal models and clinical studies. However, surgical banding or chronic hypoxia animal models do not fully reproduce the etiology of human PH, whereas invasive clinical measurements of pulmonary vascular resistance (PVR), stiffness and ventricular elastance provide limited insight into disease progression. Therefore, there is a pressing need to develop a multi-scale (MS) computational model that can couple the short term (e.g. hemodynamics) and long-term G\&R interactions between the RV and the pulmonary circulation.
The overall goals of this project are to use the framework to (1) describe the time course of the biomechanical alterations and (2) identify the key mechanical culprits associated with PH-induced heart failure so that clinical interventions can be targeted against them.
- Being tested
- cardiac catheterization, Cardiac MRI
- Medical subject headings
- Hypertension, Pulmonary, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac catheterizationProcedure or surgery
cardiac catheterizations will be clinically indicated and the study will collect this clinical data.
Cardiac MRIRadiation
If clinically indicated, the study will collect data from MRIs.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension | Participants diagnosed with pulmonary hypertension that will undergo a clinically indicated cardiac catheterization and cMRI. Receives: Procedure: cardiac catheterization; Radiation: Cardiac MRI | |
| Heart Transplant | Successful cardiac transplant recipient without evidence of pulmonary hypertension, that will undergo clinically indicated cardiac catheterization. Receives: Procedure: cardiac catheterization; Radiation: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D volumetric data (mL/m2)
Modeling framework will be validated using 3D volumetric data (mL/m2) gathered via cardiac MRI
Measured: 1 hour
Cardiopulmonary Flow (mL/beat)
Modeling framework will be validated using cardiopulmonary flow (mL/beat) gathered via cardiac MRI
Measured: 1 hour
Mean Pressure (mmHg)
Modeling framework will be validated using pressures (mmHg) gathered via cardiac catheterization
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Apr 2017
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, Nationwide Children's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alberto Figueroa, University of Michigan
- Investigators
- Alberto Figueroa, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564522
- Sponsor's protocol ID
- HUM00117706
- Other IDs
- U01HL135842
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2018
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-based Multi-scale Modeling Framework of the Cardiopulmonary System: Longitudinal Calibration and Assessment of Therapies in Pediatric Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03564522
- Acronym / sponsor ID
- HUM00117706
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan State University, Nationwide Children's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 21 Jun 2018 (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.
This study looks to develop a multi-scale computational model of Pulmonary Hypertension, this clinical model will be calibrated using longitudinal, retrospectively and prospectively acquired human clinical data.
Detailed description
Pulmonary hypertension (PH) is a complex disorder associated with elevated pulmonary arterial pressure. Unlike systemic hypertension, PH is difficult to detect in routine physical examinations and the current gold standard for diagnosing PH is through invasive right heart catheterization. Prolonged PH results in functional, structural and anatomical changes in the right ventricle (RV), large pulmonary arteries, and the pulmonary micro-circulation that ultimately lead to decompensated RV failure and death. Unlike in systemic hypertension, for which patients have effective pharmacological management of blood pressure for decades, PH prognosis remains poor with 15% mortality within 1 year on modern therapy. Our current understanding of PH has largely been obtained through animal models and clinical studies. However, surgical banding or chronic hypoxia animal models do not fully reproduce the etiology of human PH, whereas invasive clinical measurements of pulmonary vascular resistance (PVR), stiffness and ventricular elastance provide limited insight into disease progression. Therefore, there is a pressing need to develop a multi-scale (MS) computational model that can couple the short term (e.g. hemodynamics) and long-term G\&R interactions between the RV and the pulmonary circulation.
The overall goals of this project are to use the framework to (1) describe the time course of the biomechanical alterations and (2) identify the key mechanical culprits associated with PH-induced heart failure so that clinical interventions can be targeted against them.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension | – | Procedure: cardiac catheterization, Radiation: Cardiac MRIParticipants diagnosed with pulmonary hypertension that will undergo a clinically indicated cardiac catheterization and cMRI. |
| Heart Transplant | – | Procedure: cardiac catheterization, Radiation: Cardiac MRISuccessful cardiac transplant recipient without evidence of pulmonary hypertension, that will undergo clinically indicated cardiac catheterization. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pulmonary hypertension patients will be defined by a mean artery blood pressure >25 mmHg. Transplant patients are tested for pulmonary vascular resistance prior to transplant; if it is too high, transplant is contraindicated. So this group comprises patients who have normal right ventricular function and pulmonary vascular function to act as a control for the right-sided disease that we are testing, and in addition regularly undergo cardiac catheterization for clinical purposes.
Key inclusion criteria (2 listed)
- Patients has been clinically diagnosed with pulmonary hypertension (>25 mmHg) or patient is a biopsy-proven non-rejecting cardiac transplant recipient
- Receiving partial or full care from pediatric cardiology team at Mott Children's Hospital (may have a primary cardiologist elsewhere).
Key exclusion criteria (8 listed)
- Girls and women who are pregnant or actively trying to become pregnant
- Patients with significant neurocognitive impairment that precludes their ability to sign a consent form
- Patient has a contraindication to right-heart catheterization (RHC) examination, which includes patients with hypoxia and those who have difficulty maintaining supine position for the procedure.
- Patients with the following genetic syndromes:Trisomy 21 if unable to assent or consent, Trisomy 18,Trisomy 13, Other genetic syndromes at the discretion of the Primary Investigator
- Patients with unrepaired single ventricles (i.e., Pre-Fontan physiology)
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 |
|---|---|---|
| cardiac catheterizationcardiac catheterizations will be clinically indicated and the study will collect this clinical data. | Procedure or surgery | Heart Transplant, Pulmonary Hypertension |
| Cardiac MRIIf clinically indicated, the study will collect data from MRIs. | Radiation | Heart Transplant, Pulmonary Hypertension |
Primary outcome
3D volumetric data (mL/m2)
Time frame: 1 hour
Modeling framework will be validated using 3D volumetric data (mL/m2) gathered via cardiac MRI
Cardiopulmonary Flow (mL/beat)
Time frame: 1 hour
Modeling framework will be validated using cardiopulmonary flow (mL/beat) gathered via cardiac MRI
Mean Pressure (mmHg)
Time frame: 2 hours
Modeling framework will be validated using pressures (mmHg) gathered via cardiac catheterization
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 18 Apr 2024.
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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.
Alberto Figueroa, Ph.D. principal investigator
University of Michigan
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 Hypertension and Congenital Heart Disease, run by University of Michigan 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 2 inclusion and 8 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 18 Apr 2024. 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?
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?
3D volumetric data (mL/m2) (time frame: 1 hour). The study lists 3 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 18 Apr 2024.