Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Description

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.

Conditions

Mitral Regurgitation

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Study Overview

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Study Details

Study overview

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.

Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Condition
Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

New York

Montefiore Medical Center, New York, New York, United States, 10470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Montefiore Medical Center,

Mario Garcia, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2025-06