Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction
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| ClinicalTrials.gov Identifier: NCT00998205 |
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Recruitment Status :
Completed
First Posted : October 20, 2009
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diastolic Dysfunction | Drug: Dobutamine stress echo (DSE) Drug: Atropine bolus | Not Applicable |
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 Advanced Cardiac Life Support (ACLS) certified nurses and doctors.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Early Diagnosis of Diastolic Dysfunction and Reliability of Dobutamine Stress Echo (DSE) in Detecting Stress Diastolic Dysfunction |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Dobutamine stress echo (DSE)
Dobutamine intravenous infusion would be undertaken starting at 10 micro-grams/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micro-grams/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate.
Other Name: Dobutamine hydrochloride Drug: Atropine bolus 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.
Other Name: Atropine sulfate |
- Change in Left Ventricle Mean Diastolic Pressure [ Time Frame: Baseline, recovery ]Left ventricle filling pressures were measured using a pigtail catheter inserted into the left ventricle. Measurements of left ventricle pressures were taken at baseline, 3 minutes, 6 minutes, 9 minutes, 12 minutes, and recovery. Change from baseline at recovery reported.
- Change in Early Transmitral Velocity/Early Lateral Mitral Velocity (E/E') [ Time Frame: Baseline, recovery ]Echocardiography was performed at rest and with dobutamine stress at 3 minutes, 6 minutes, 9 minutes, and 12 minutes, to measure differences in E/E' at the septum and lateral mitral annulus. Change from baseline at recovery reported.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Prospectively enroll 25 veterans age range from 18 to 65 who are found to have normal left ventricular (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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998205
| United States, Missouri | |
| University of Missouri | |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: | Anand Chockalingam, MD | University of Missouri/Harry S Truman VA Hospital |
| Responsible Party: | University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00998205 |
| Other Study ID Numbers: |
1115797 |
| First Posted: | October 20, 2009 Key Record Dates |
| Results First Posted: | April 6, 2017 |
| Last Update Posted: | April 6, 2017 |
| Last Verified: | April 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Atropine Dobutamine Adjuvants, Anesthesia Anti-Arrhythmia Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Mydriatics Parasympatholytics |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Sympathomimetics Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Protective Agents |