Using phenylephrine to assess mitral regurgitation severity

Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography

This study is testing whether giving a medication called phenylephrine during heart scans can help doctors better understand how severe mitral regurgitation is in patients.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montefiore Medical Center (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT04500899 on ClinicalTrials.gov

What this trial studies

This study aims to develop a protocol using intravenous phenylephrine during transesophageal echocardiography to increase afterload and mimic the hemodynamic profile of normal physical activity. By doing so, it seeks to provide a more accurate quantification of mitral regurgitation (MR) severity, which is often underestimated during routine echocardiography due to sedation effects. The study will compare MR severity grades before and after phenylephrine administration, with the goal of demonstrating a 25% increase in severity compared to baseline conditions. This approach could enhance clinical decision-making regarding treatment options for patients with MR.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 and older with mitral regurgitation scheduled for transesophageal echocardiography.

Not a fit: Patients with contraindications to transesophageal echocardiography or those with significant hemodynamic instability will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of mitral regurgitation severity, improving treatment decisions for affected patients.

How similar studies have performed: While the use of phenylephrine in this context is innovative, similar studies have shown that hemodynamic assessments can improve diagnostic accuracy.

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.

Where this trial is running

New York, New York

• Montefiore Medical Center — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Mario Garcia, MD — Montefiore Medical Center
• Study coordinator: Mario Garcia, MD

Conditions Mitral Regurgitation