Clinical trial NCT01778894: Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart
Official title: Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diastolic Heart Failure
Keywords: Diastolic Dysfunction, Diastolic Heart Failure, Diastolic
Echocardiography
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal controls will be recruited from the Omaha community. Subjects with Diastolic Heart Dysfunction and/or Failure will be selected from The University of Nebraska Medical Center Heart Clinic or from The Nebraska Medical Center Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The longitudinal assessment of myocardial properties in subjects with Diastolic Heart Failure.
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of observed muscle properties to clinical outcomes/status.
timeFrame: 2 years
measure: Validation of the developing mathematical model using the data points collected from echocardiographic procedures
timeFrame: 1 baseline echocardiograph
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Moulton J Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kass DA, Bronzwaer JG, Paulus WJ. What mechanisms underlie diastolic dysfunction in heart failure? Circ Res. 2004 Jun 25;94(12):1533-42. doi: 10.1161/01.RES.0000129254.25507.d6.
citation: Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.
citation: Moulton MJ, Creswell LL, Actis RL, Myers KW, Vannier MW, Szabo BA, Pasque MK. An inverse approach to determining myocardial material properties. J Biomech. 1995 Aug;28(8):935-48. doi: 10.1016/0021-9290(94)00144-s.