Investigation of Myocardial Contractile Reserve by Dobutamine Stress Transesophageal Echocardiography in Aortic and Mitral Regurgitation
Data Collection
Aortic Valve Disease+3
+ Cardiovascular Diseases
+ Heart Diseases
Summary
Study start date: May 1, 1992
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total 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.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps