Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart

University of Nebraska

Status: Terminated

Conditions: Diastolic Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01778894

0623-12-EP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

37 participants in 2 patient groups

Healthy Control

Description:

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

Description:

Diastolic Heart Failure, \> Grade II (NYHA functional class) and/or \> Grade II Diastolic Dysfunction as evaluated by echocardiography