Search / Trial NCT00001314

Investigation of Heart Function in Patients With Heart Valve Defects

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Dec 9, 2002

Apply for Trial

Trial Information

Current as of April 22, 2024

Completed

Keywords

Aortic Regurgitation Dobutamine Stress Left Ventricular Function Mitral Regurgitation Myocardial Contractile Reserve Transesophageal Echocardiography

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.

Gender

All

Eligibility 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.

Attachments

readout_NCT00001314_2024-04-22.pdf

4.5 MB

NCT00001314_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0