Aortic Valve InsufficiencyNCT00001314
Investigation of Heart Function in Patients With Heart Valve Defects
An observational study of Aortic Valve Insufficiency and Mitral Valve Insufficiency, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Insufficiency, Mitral Valve Insufficiency
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 1992to Mar 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed 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.
- Keywords
- Aortic Regurgitation, Dobutamine Stress, Left Ventricular Function, Mitral Regurgitation, Myocardial Contractile Reserve, Transesophageal Echocardiography
- Medical subject headings
- Aortic Valve Insufficiency, Mitral Valve Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMay 1992
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001314
- Sponsor's protocol ID
- 920195
- Other IDs
- 92-H-0195
- Status last verified
- Apr 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 3882814Bonow 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.
PubMed 6872164Bonow 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.
PubMed 1914102
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Myocardial Contractile Reserve by Dobutamine Stress Transesophageal Echocardiography in Aortic and Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT00001314
- Acronym / sponsor ID
- 920195
- Keywords
- Aortic Regurgitation, Dobutamine Stress, Left Ventricular Function, Mitral Regurgitation, Myocardial Contractile Reserve, Transesophageal Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1992
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3882814Ross 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.
- Background: PubMed 6872164Bonow 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.
- Background: PubMed 1914102Bonow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Insufficiency and Mitral Valve Insufficiency, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001314, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.