Early Diagnosis of Diastolic Dysfunction and Reliability of Dobutamine Stress Echo (DSE) in Detecting Stress Diastolic Dysfunction
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diastolic Dysfunction |
Drug: Dobutamine stress echo (DSE) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction |
- Evaluate the reliability of DSE in tracking diastolic function, i.e., filling pressures. [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]
- Measure E/E' at rest and with dobutamine stress with a target heart rate of at least 85% of age predicted maximal heart rate. [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Dobutamine stress echo (DSE) |
Drug: Dobutamine stress echo (DSE)
Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Missouri | |
| University of Missouri | |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: | Anand Chockalingam, MD | University of Missouri/Harry S Truman VA Hospital |
More Information
No publications provided
| Responsible Party: | Anand Chockalingam, MD, Assistant Professor of Clinical Medicine, University of Missouri |
| ClinicalTrials.gov Identifier: | NCT00998205 History of Changes |
| Other Study ID Numbers: | 1115797 |
| Study First Received: | October 19, 2009 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dobutamine Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 22, 2013