Investigation of Heart Function in Patients With Heart Valve Defects

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00001314
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	N/A
Start date	May 1992
Completion date	March 2001

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.