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Early Diagnosis of Diastolic Dysfunction and Reliability of Dobutamine Stress Echo (DSE) in Detecting Stress Diastolic Dysfunction

Information source: University of Missouri-Columbia
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diastolic Dysfunction

Intervention: Dobutamine stress echo (DSE) (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Missouri-Columbia

Official(s) and/or principal investigator(s):
Anand Chockalingam, MD, Principal Investigator, Affiliation: University of Missouri/Harry S Truman VA Hospital

Summary

The heart becoming "stiff" due to increased fibrous tissue or decreased elasticity of the heart tissue is one of the earliest changes caused by heart failure. These changes can be detected by simple non-invasive echocardiogram techniques. However, these techniques usually detect the increased "stiffness" of the heart only after it has progressed to a significant extent. The investigators hypothesize that if they stress the heart using a Dobutamine infusion and measure the filling pressure using echocardiogram, it will provide them with tools to identify these changes earlier. The investigators are planning to include people have normal heart function. It is standard procedure to measure cardiac pressure during catheterization. Simultaneously, the investigators will infuse Dobutamine (standard drug used for chemical stress testing, DSE). This drug increases the heart rate and mimics exercise in normal humans who are unable to exercise for various reasons. The investigators would continue to monitor the pressure inside the heart as they infuse Dobutamine and see of there is an increase in filling pressure. The investigators will correlate the invasive pressures with their echo derived measurements. The investigators plan to include 25 veterans in this study. For each individual the study would increase the amount of time they will spend in the Catheterization Lab from 30 to 120 minutes. The entire procedure will be monitored by ACLS certified nurses and doctors.

Clinical Details

Official title: Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Evaluate the reliability of DSE in tracking diastolic function, i.e., filling pressures.

Secondary outcome: Measure E/E' at rest and with dobutamine stress with a target heart rate of at least 85% of age predicted maximal heart rate.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Prospectively enroll 25 veterans age range from 18 to 65 who are found to have normal

LV systolic function and no significant coronary artery disease by cardiac catheterization.

- Subjects identified during routine cardiac testing to have significant diastolic

dysfunction may also be enrolled to rule out coronary disease and study DSE - invasive

pressure correlations. Exclusion criteria:

- Patients with LV systolic dysfunction, severe coronary lesions (> 50%), uncontrolled

hypertension (BP > 160/100) and significant pulmonary hypertension (PASP > 50 mmHg) would be excluded.

- Subject will not be included if they have a significant rhythm abnormality, frequent

premature ventricular complexes, atrial fibrillation and technical reasons in the catheterization laboratory which preclude the study protocol.

Locations and Contacts

University of Missouri, Columbia, Missouri 65212, United States
Additional Information

Starting date: June 2008
Last updated: June 15, 2011

Page last updated: August 20, 2015

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