Other Clinical Trial - Image-based Multi-scale Modeling Framework of

Status Completed

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03564522
Study type	Observational
Source	University of Michigan
Contact
Status	Completed
Phase
Start date	April 1, 2017
Completion date	July 28, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms