- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001314
Investigation of Heart Function in Patients With Heart Valve Defects
Investigation of Myocardial Contractile Reserve by Dobutamine Stress Transesophageal Echocardiography in Aortic and Mitral Regurgitation
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. doi: 10.1016/s0735-1097(85)80418-6.
- 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. doi: 10.1161/01.cir.68.3.509. 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. doi: 10.1161/01.cir.84.4.1625.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 920195
- 92-H-0195
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mitral Valve Insufficiency
-
Abbott Medical DevicesCompletedMitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Functional Mitral Regurgitation | Mitral Stenosis With InsufficiencyJapan
-
4C Medical Technologies, Inc.Not yet recruitingMitral Regurgitation | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Mitral Incompetence
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
-
Abbott Medical DevicesRecruitingCardiovascular Diseases | Heart Valve Diseases | Mitral Regurgitation | Mitral Valve Insufficiency | Valve Disease, Heart | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
-
Edwards LifesciencesActive, not recruitingMitral Regurgitation | Mitral Insufficiency | Mitral Repair | Mitral Valve | Annuloplasty | Edwards CardiobandSwitzerland, Germany, Italy
-
4C Medical Technologies, Inc.RecruitingMitral Regurgitation | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Mitral IncompetenceUnited States
-
Edwards LifesciencesRecruitingMitral Regurgitation | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada, Switzerland, Germany