Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Nebraska
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- The longitudinal assessment of myocardial properties in subjects with Diastolic Heart Failure.
Overview
Brief Summary
According to the most recent information released by the American Heart Association, heart failure affects 5.8 million Americans and over 23 million people worldwide. In particular, diastolic heart failure (DHF) has emerged in approximately half of those suffering from heart disease and has become a major public health problem for many reasons, including the complexity of the disease, lack of effective drugs/therapies, requirement of invasive tests to diagnose and monitor DHF, and the absence of a suitable scientific model to study the disease. Scientists and physicians alike still do not fully understand what happens to the muscles in the heart (myocardium) patients who present with diastolic dysfunction or DHF. Therefore, the medical field is in need of an accurate model that can evaluate how diastolic dysfunction leads to heart failure and what happens at a cellular level as this disease emerges and progresses.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects must be 19 years of age or older
- •Control subjects must have no prior history or current signs of heart disease.
- •Subjects with heart failure must meet one or more of the following criteria:
- •Documented Diastolic Heart Failure, Grade II or greater (via NYHA functional class)
- •Grade II or greater Diastolic Dysfunction by echocardiographic evaluation
Exclusion Criteria
- •Subjects under the age of 19 or unable to give consent will be excluded from this study.
- •Greater than mild valvular disease
- •Prior valve repair/replacement
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Validation of the developing mathematical model using the data points collected from echocardiographic procedures(1 baseline echocardiograph)
- Correlation of observed muscle properties to clinical outcomes/status.(2 years)