Investigation of Heart Function in Patients With Heart Valve Defects
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aortic Valve Insufficiency; Mitral Valve Insufficiency
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
In this study researchers plan to perform a diagnostic test called transesophageal
echocardiography in order to see and record the movement and function of the heart.
Transesophageal echocardiography is similar to an upper gastrointestinal endoscopy.
Different views of the heart are taken by a small, flexible instrument positioned in the
esophagus (the tube that connects the mouth to the stomach). This allows doctors to create a
clear picture of the heart through the wall of the esophagus rather than from outside the
body through the muscles, fat, and bones of the chest wall.
During transesophageal echocardiography pictures of the heart will be taken while patients
rest and as patients receive a medication called dobutamine. Dobutamine is a medication that
makes the heart beat stronger and faster, similar to what exercise does to the heart.
Researchers are particularly interested in studying patients with defects in the valves of
the heart, especially aortic regurgitation and mitral regurgitation. Patients with these
defects in the heart valves tend to develop abnormalities in the size and function of the
left ventricle. The left ventricle is one of the four chambers of the heart responsible for
ejecting blood out of the heart into the circulation. Researchers believe that by
identifying changes in the function of heart muscle, they may be able to predict the
occurrence of muscle damage due to the diseased valves.
The purpose of this study is to determine whether the function of heart muscle measured
during dobutamine stress transesophageal echocardiography can predict the later development
of problems in the function and size of the left ventricle.
Official title: Investigation of Myocardial Contractile Reserve by Dobutamine Stress Transesophageal Echocardiography in Aortic and Mitral Regurgitation
Study design: N/A
In this investigation, we propose to perform dobutamine stress transesophageal
echocardiography in patients with aortic regurgitation and in patients with mitral
regurgitation in order to assess myocardial contractile reserve. The purpose of the study is
to determine whether the contractile reserve of the myocardium measured during dobutamine
stress echocardiography is a predictor of the development of subsequent left ventricular
dysfunction and left ventricular dilatation, as well as recovery of left ventricular function
after surgery, in these patients.
Minimum age: N/A.
Maximum age: N/A.
18 - 65 years of age.
Patients with severe aortic regurgitation and patients with severe mitral regurgitation.
Patients will discontinue medications 48 hours prior to the study.
Women must not be pregnant.
Patients must not have an associated valvular heart disease (i. e., patients with aortic
regurgitation will be excluded if there is coexistent mitral valve disease; patients with
mitral regurgitation will be excluded if there is coexistent aortic valve disease).
Patients must not have any form of cardiomyopathy.
Patients must not have coronary artery disease.
Patients must not have ventricular ectopy during baseline conditions (i. e., couplets,
frequent PVc's [greater than 6/min], early coupling ["R-on-T" phenomenon], ventricular
bigeminy) that might potentially predispose the patient for the development of dangerous
dysrhythmia during dobutamine infusion.
Patients must not have a history of cardiac arrest or ventricular tachycardia.
Patients must not have a history of congestive heart failure.
Patients must not have hypotension (i. e., systolic blood pressure less than 100 mmHg).
Patients must not have a systolic blood pressure greater than 200 mmHg.
Patients must not have a left atrial size of greater than 100 mm.
Patients must not have atrial fibrillation.
Patients must not have sinus tachycardia greater than or equal to 100 beats/min.
Patients must not have esophageal disease.
Patients must not have any other medical condition that , at the discretion of the
physician in charge, may increase the risk of the procedure.
Locations and Contacts
National Heart, Lung and Blood Institute (NHLBI), Bethesda, Maryland 20892, United States
Ross J Jr. Afterload mismatch in aortic and mitral valve disease: implications for surgical therapy. J Am Coll Cardiol. 1985 Apr;5(4):811-26. Review.
Bonow RO, Rosing DR, McIntosh CL, Jones M, Maron BJ, Lan KK, Lakatos E, Bacharach SL, Green MV, Epstein SE. The natural history of asymptomatic patients with aortic regurgitation and normal left ventricular function. Circulation. 1983 Sep;68(3):509-17. No abstract available.
Bonow RO, Lakatos E, Maron BJ, Epstein SE. Serial long-term assessment of the natural history of asymptomatic patients with chronic aortic regurgitation and normal left ventricular systolic function. Circulation. 1991 Oct;84(4):1625-35.
Starting date: May 1992
Ending date: March 2001
Last updated: March 3, 2008