Completed

Investigation of Heart Function in Patients With Heart Valve Defects

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What is being collected

Data Collection

Who is being recruted

Aortic Valve Insufficiency

+ Mitral Valve Insufficiency
How is the trial designed

Other

Observational
Study Start: May 1992

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 1992Actual date on which the first participant was enrolled.

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. 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.

Official TitleInvestigation of Myocardial Contractile Reserve by Dobutamine Stress Transesophageal Echocardiography in Aortic and Mitral Regurgitation 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Aortic Valve Insufficiency
Mitral Valve Insufficiency
Criteria

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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Heart, Lung and Blood Institute (NHLBI)Bethesda, United StatesSee the location

CompletedOne Study Center