Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Recruiting now · Phase 1/Phase 2

Conditions studied: Mitral Regurgitation

In brief

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.

Key facts

Study ID

NCT04500899

Run by

Montefiore Medical Center

People needed

35

Starts

2020-12-01

Expected to finish

2026-06-01

Last updated by the study team

2025-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Montefiore Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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