Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2025 by Montefiore Medical Center
Sponsor
Montefiore Medical Center
Information Provided by (Responsible Party)
Montefiore Medical Center
Clinicaltrials.gov Identifier
NCT04500899
Other Study ID Numbers:
2020-11414
First Submitted
July 22, 2020
First Posted
August 4, 2020
Last Update Posted
July 19, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Mitral Regurgitation
Drug: Mydfrin

Study Design

Study TypeInterventional
Actual Enrollment35 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeDiagnostic
Official TitleEvaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography
Study Start DateNovember 30, 2020
Actual Primary Completion DateMay 31, 2026
Actual Study Completion DateMay 31, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
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. 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.

Outcome Measures

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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsMontefiore Medical Center
Locations
Montefiore Medical Center | New York New York, United States, 10470
Investigators
Principal Investigator: Mario Garcia, MD, Montefiore Medical Center