Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04500899

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Led by Montefiore Medical Center · Updated on 2025-07-20

35

Participants Needed

1

Research Sites

286 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

B

Baylor College of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older with mitral regurgitation on baseline echocardiographic evaluation
  • Patients scheduled to undergo transesophageal echocardiography for further evaluation of mitral regurgitation
Not Eligible

You will not qualify if you...

  • Patients not clinically eligible for transesophageal echocardiography
  • Patients with contraindications to esophageal intubation
  • Patients with hemodynamic instability
  • Patients with acute decompensated heart failure
  • Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease)
  • Patients with ongoing unstable angina or ongoing myocardial infarction
  • Patients with significant arrhythmias including atrial fibrillation
  • Patients with uncontrolled hypertension (blood pressure 64; 150/90 mmHg)
  • Patients with preexisting bradycardia (heart rate < 50) and heart blocks
  • Patients with severe symptomatic peripheral vascular disease
  • Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure 64; 60 mm Hg)
  • Patients at high risk for intracranial bleeding such as those with previous strokes, transient ischemic attack, or vascular malformations
  • Patients with mean arterial blood pressure greater than 100 mmHg during TEE
  • Patients with severe mitral regurgitation (effective regurgitant orifice area > 39 cm2) on baseline TEE evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

New York, New York, United States, 10470

Actively Recruiting

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Research Team

M

Mario Garcia, MD

CONTACT

W

Waqas Hanif, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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