Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart
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|ClinicalTrials.gov Identifier: NCT01778894|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2013
Last Update Posted : April 27, 2018
|Condition or disease|
|Diastolic Heart Failure|
Our group has developed a mathematical model of the heart that gathers data from a procedure called an echocardiograph (echo) to analyze how muscles in the heart are functioning. This model incorporates how the heart muscle functions on a cellular level along with the overall functionality of the heart.
We hypothesize that this model will measure the specific properties of the heart muscle that affect their ability to contract and relax. This study will determine whether these properties will be different in patients with DHF compared to healthy controls. We also propose that these abnormalities in the heart muscle will correlate with the patient's degree of heart failure and their prognosis when doctors evaluate using standard clinical tests.
This study will be conducted at the University of Nebraska Medical Center (UNMC). 40 subjects will be enrolled, 20 healthy controls with no history of heart disease and 20 subjects who have been diagnosed with diastolic heart failure. Healthy controls will be required to undergo 1 echocardiograph procedure at UNMC. Subjects diagnosed with DHF will be required to undergo 6 echocardiograph procedure over the course of 2 years.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||January 1, 2022|
Healthy controls with no history of heart disease or heart failure. Subjects will undergo a medical history review and 1 echocardiograph procedure.
>Grade 2 Diastolic Dysfunction
Diastolic Heart Failure, > Grade II (NYHA functional class) and/or > Grade II Diastolic Dysfunction as evaluated by echocardiography
- The longitudinal assessment of myocardial properties in subjects with Diastolic Heart Failure. [ Time Frame: 2 years ]Our mathematical model of the heart integrates the cellular mechanisms of sarcomere dynamics with the overall functional properties of the ventricle. Utilizing specific measurements captured by echo, estimates of basic muscle properties in subjects suffering from DHF will be compared to observed properties. Echo measurements will be taken at baseline and 2 weeks, 4 months, 8 months, 1 year, and 2 years following therapy.
- Correlation of observed muscle properties to clinical outcomes/status. [ Time Frame: 2 years ]Clinical outcome measurements, including hospitalizations, New York Heart Association (NYHA) class, and mortality, will be collected to determine effectiveness of current therapy for diastolic heart failure. By tracking patient outcomes and measured clinical endpoints, the degree of material parameter abnormality affecting clinical outcomes of subjects will be tested using multivariate regression with the material parameters derived from the model. The dependent variables and covariates such as age, sex, ejection fraction, presence of co-morbidities such as coronary artery disease, diabetes, and hypertension will also be included in the analysis.
- Validation of the developing mathematical model using the data points collected from echocardiographic procedures [ Time Frame: 1 baseline echocardiograph ]An optimization driver program that controls the parameter estimation has been developed and will be validated. To estimate unknown material parameters, multiple forward model simulations are obtained to estimate the partial derivatives of the least squares objective function with respect to the material parameters. Best-fit parameters will be determined for each DHF patient and each control using cylindrical, spherical and ellipsoidal models. Each of these parameters represents a unique aspect of sarcomere and ventricular matrix constitutive behavior. Best-fit material parameters for each patient will be compared with those obtained from the control groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778894
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Moulton J Moulton, MD||University of Nebraska|