Brief Summary
The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby intravenous phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic profile and variation that occurs with normal physical activity. The expectation is to see changes in severity of Mitral Regurgitation (MR) grade with increasing afterload, which in turn can provide more accurate quantification of MR severity to assist in clinical decision making.
Brief Title
Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
Detailed Description
Routine echocardiography which is used to assess the severity of mitral regurgitation, sometimes underestimates the severity of mitral regurgitation, due to hemodynamic variations that occurs with normal physical activity and under the effect of sedation which is used to perform transesophageal echocardiography. By using phenylephrine during transesophageal echocardiography, the study intends to offset the hemodynamic variation that occurs with sedation and better assess the severity of mitral regurgitation, which would further assist in clinical decision-making regarding treatment. The goal of this study is to compare the severity of mitral regurgitation grade before and after the administration of phenylephrine during transesophageal echocardiography and to demonstrate a 25% increase in severity of mitral regurgitation grade compared to the baseline conditions, following the administration of phenylephrine.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-920-4172
Central Contact Email
mariogar@montefiore.org
Central Contact Role
Contact
Central Contact Phone
646-270-1421
Central Contact Email
whanif@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Mitral Regurgitation
Eligibility Criteria
Inclusion Criteria:
* Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
Exclusion Criteria:
* The following patients will be excluded from the study:
1. Patients who are not clinically eligible for TEE.
2. Patients with contraindications to esophageal intubation.
3. Patients with hemodynamic instability.
4. Patients with acute decompensated heart failure (HF).
5. Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease).
6. Patients with ongoing unstable angina or ongoing myocardial infarction (MI)
7. Patients with significant arrhythmias including atrial fibrillation.
8. Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg).
9. Patients with preexisting bradycardia (HR \< 50) and heart blocks.
10. Patients with severe symptomatic peripheral vascular disease.
11. Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure sPAP ≥ 60mm Hg).
12. Patients who are at high risk for intracranial bleeding such as patients with previous strokes, transient ischemic attack (TIA) and vascular malformations.
13. Additionally, patients with mean arterial blood pressure MAP \> 100 mmHg during TEE and those with severe MR, effective regurgitant orifice area (ERO \> 39cm2) on baseline TEE evaluation will not be given phenylephrine and excluded from the study.
* Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
Exclusion Criteria:
* The following patients will be excluded from the study:
1. Patients who are not clinically eligible for TEE.
2. Patients with contraindications to esophageal intubation.
3. Patients with hemodynamic instability.
4. Patients with acute decompensated heart failure (HF).
5. Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease).
6. Patients with ongoing unstable angina or ongoing myocardial infarction (MI)
7. Patients with significant arrhythmias including atrial fibrillation.
8. Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg).
9. Patients with preexisting bradycardia (HR \< 50) and heart blocks.
10. Patients with severe symptomatic peripheral vascular disease.
11. Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure sPAP ≥ 60mm Hg).
12. Patients who are at high risk for intracranial bleeding such as patients with previous strokes, transient ischemic attack (TIA) and vascular malformations.
13. Additionally, patients with mean arterial blood pressure MAP \> 100 mmHg during TEE and those with severe MR, effective regurgitant orifice area (ERO \> 39cm2) on baseline TEE evaluation will not be given phenylephrine and excluded from the study.
Inclusion Criteria
Inclusion Criteria:
* Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
* Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04500899
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-11414
Overall Status
Recruiting
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography
Primary Outcomes
Outcome Description
The purpose of this study is to compare the echocardiographic parameters of MR grade before and after the use of phenylephrine during transesophageal echocardiography (TEE) and to document an increase in echocardiographic parameters of MR grade after the use of phenylephrine.
Outcome Measure
The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.
Outcome Time Frame
Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mario Garcia
Investigator Email
mariogar@montefiore.org
Investigator Phone
718-920-4172