Using phenylephrine to assess mitral regurgitation severity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mariogar@montefiore.org
• Phone: 718-920-4172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.