Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Last updated: July 5, 2024
Sponsor: Montefiore Medical Center
Overall Status: Active - Recruiting

Phase

1/2

Condition

Congestive Heart Failure

Mitral Valve Regurgitation

Treatment

Mydfrin

Clinical Study ID

NCT04500899
2020-11414
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years or older with MR on baseline echocardiographic evaluation who arescheduled to undergo TEE for further evaluation of mitral regurgitation.

Exclusion

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 vesselor 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 pulmonaryarterial pressure sPAP ≥ 60mm Hg).

  12. Patients who are at high risk for intracranial bleeding such as patients withprevious strokes, transient ischemic attack (TIA) and vascular malformations.

  13. Additionally, patients with mean arterial blood pressure MAP > 100 mmHg duringTEE and those with severe MR, effective regurgitant orifice area (ERO > 39cm2)on baseline TEE evaluation will not be given phenylephrine and excluded fromthe study.

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Mydfrin
Phase: 1/2
Study Start date:
December 01, 2020
Estimated Completion Date:
June 30, 2025

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.

Connect with a study center

  • Montefiore Medical Center

    New York, New York 10470
    United States

    Active - Recruiting

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