Image-based Multi-scale Modeling Framework of the Cardiopulmonary System: Longitudinal Calibration and Assessment of Therapies in Pediatric Pulmonary Hypertension

NCT03564522 | Completed

• 2 other identifiers: HUM00117706U01HL135842
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pulmonary Hypertension; Congenital Heart Disease; Pediatric Congenital Heart Disease

Outcome Measures

Primary Outcomes (3)

• 3D volumetric data (mL/m2)

  Modeling framework will be validated using 3D volumetric data (mL/m2) gathered via cardiac MRI

  1 hour

• Cardiopulmonary Flow (mL/beat)

  Modeling framework will be validated using cardiopulmonary flow (mL/beat) gathered via cardiac MRI

  1 hour

• Mean Pressure (mmHg)

  Modeling framework will be validated using pressures (mmHg) gathered via cardiac catheterization

  2 hours

Study Arms (2)

Pulmonary Hypertension

Participants diagnosed with pulmonary hypertension that will undergo a clinically indicated cardiac catheterization and cMRI.

Procedure: cardiac catheterization; Radiation: Cardiac MRI

Heart Transplant

Successful cardiac transplant recipient without evidence of pulmonary hypertension, that will undergo clinically indicated cardiac catheterization.

Procedure: cardiac catheterization; Radiation: Cardiac MRI

Interventions

cardiac catheterization PROCEDURE

cardiac catheterizations will be clinically indicated and the study will collect this clinical data.

Heart Transplant; Pulmonary Hypertension

Cardiac MRI RADIATION

If clinically indicated, the study will collect data from MRIs.

Heart Transplant; Pulmonary Hypertension

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Michigan State University: collaborator
• Nationwide Children's Hospital: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Mott Children's Hospital University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Defects, Congenital

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Alberto Figueroa, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edward B Diethrich M.D. Research Professor of Biomedical Engineering and Vascular Surgery

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: June 21, 2018
• Study Start: April 1, 2017
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (2)