Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:4/29/2018
Start Date:September 2013
End Date:January 1, 2022

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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.

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.

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
We found this trial at
1
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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