Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

July 18, 2023 updated by: Montefiore Medical Center

Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10470
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Mario Garcia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mydfrin
Phenylephrine is available as phenylephrine hydrochloride injection, 10 mg/mL in 1 mL vial. For intravascular bolus administration, the investigators will prepare a solution containing 100 mcg/mL of phenylephrine hydrochloride, by withdrawing 10 mg (1ml of 10mg/mL) of phenylephrine injection and diluting with 99 mL of 5% dextrose injection or 0.9% sodium chloride injection.
Drug: Mydfrin
A test dose of 20 mcg of Mydfrin will be administered through the peripheral intravenous line. Subsequent Mydfrin injections will then be administered in 40 mcg aliquots every 10-15 minutes, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Mario Garcia, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-11414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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