Studying Phenylephrine for Mitral Regurgitation Assessment

This study is looking at how a medication called Mydfrin (phenylephrine) can help doctors better understand the severity of mitral regurgitation (MR). MR is a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. When you have a transesophageal echocardiography (TEE) to check your MR, you are usually sedated, which can affect the results. Mydfrin is given through an IV to temporarily increase your blood pressure, mimicking how your heart works during normal activity. The goal is to see if Mydfrin helps show a more accurate picture of your MR severity, which can help doctors make better treatment decisions. To be eligible, you must be 18 or older, have MR, and be scheduled for a TEE. The study will be considered successful if at least 25% of patients show an increase in the amount of blood leaking backward after receiving Mydfrin during their TEE. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 35 participants. It is not specified if the study is randomized or blinded.
What's involved
You would receive Mydfrin through an IV during your transesophageal echocardiography. Your blood pressure will be monitored, and additional doses of Mydfrin may be given over approximately 40 minutes.
Compensation
Not stated in the trial record.
Follow-up
Your mitral regurgitation will be measured before and after Mydfrin administration during the transesophageal echocardiography, which takes approximately 40 minutes.

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NCT04500899

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Montefiore Medical Center
~35 participants
Updated 2025-07-20 on ClinicalTrials.gov
What's tested:Mydfrin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.
Measured over Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes
Mitral Regurgitation
1 sites across 1 states
New York1
  • Mario Garcia, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

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Eligibility criteria

Inclusion

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

Exclusion

The following patients will be excluded from the study:
  • The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes

    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.