Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart

NCT01778894 | Terminated

• 1 other identifier: 0623-12-EP
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Heart Failure

Keywords

Diastolic Dysfunction, Diastolic Heart Failure, Diastolic; Echocardiography

Outcome Measures

Primary Outcomes (1)

• The longitudinal assessment of myocardial properties in subjects with Diastolic Heart Failure.

  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.

  2 years

Secondary Outcomes (2)

• Correlation of observed muscle properties to clinical outcomes/status.

  2 years

• Validation of the developing mathematical model using the data points collected from echocardiographic procedures

  1 baseline echocardiograph

Study Arms (2)

Healthy Control

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (3)

• 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.

  PMID: 15217918 BACKGROUND

• 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.

  PMID: 17428822 BACKGROUND

• 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.

  PMID: 7673261 BACKGROUND

MeSH Terms

Conditions

Heart Failure, Diastolic; Heart Murmurs

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moulton J Moulton, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: September 1, 2013
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)