Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04500899

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Montefiore Medical Center

New York, 10470, United States

Location status: Recruiting

Location contact

Mario Garcia, MD

CONTACT

About this study

Routine echocardiography which is used to assess the severity of mitral regurgitation, sometimes underestimates the severity of mitral regurgitation, due to hemodynamic variations that occurs with normal physical activity and under the effect of sedation which is used to perform transesophageal echocardiography. By using phenylephrine during transesophageal echocardiography, the study intends to offset the hemodynamic variation that occurs with sedation and better assess the severity of mitral regurgitation, which would further assist in clinical decision-making regarding treatment. The goal of this study is to compare the severity of mitral regurgitation grade before and after the administration of phenylephrine during transesophageal echocardiography and to demonstrate a 25% increase in severity of mitral regurgitation grade compared to the baseline conditions, following the administration of phenylephrine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Patients who are not clinically eligible for TEE.
  • Patients with contraindications to esophageal intubation.
  • Patients with hemodynamic instability.
  • Patients with acute decompensated heart failure (HF).
  • Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease).
  • Patients with ongoing unstable angina or ongoing myocardial infarction (MI)
  • Patients with significant arrhythmias including atrial fibrillation.
  • Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg).
  • Patients with preexisting bradycardia (HR < 50) and heart blocks.
  • Patients with severe symptomatic peripheral vascular disease.
  • Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure sPAP ≥ 60mm Hg).
  • Patients who are at high risk for intracranial bleeding such as patients with previous strokes, transient ischemic attack (TIA) and vascular malformations.
  • 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.

Treatment and study plan

Mydfrin

Drug

A test dose of 20 mcg of Mydfrin will be administered through the peripheral intravenous line. BP will be monitored after each bolus of phenylephrine. Subsequent Mydfrin injections will then be administered in 50 mcg aliquots every 10-15 minutes, instead of 40 mcg, until the mean arterial blood pressure (MAP) increases by ≥ 20 mm Hg from the baseline MAP, however making sure not to exceed a MAP of 100 mmHg. Once a desired blood pressure has been achieved and maintained, echocardiographic evaluation of mitral regurgitation would be performed.

Other names: Phenylephrine

Primary outcomes

  1. The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Garcia, MD

CONTACT

[email protected]

718-920-4172

Waqas Hanif, MD

CONTACT

[email protected]

646-270-1421

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Baylor College of Medicine

Registry information

Official study title

Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2020
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.