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
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