Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Launched by MONTEFIORE MEDICAL CENTER · Aug 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called phenylephrine to help doctors better understand the severity of a heart condition known as mitral regurgitation (MR). Mitral regurgitation happens when the heart's mitral valve does not close properly, allowing blood to flow backward into the heart. The researchers want to see if giving phenylephrine can mimic the changes in blood pressure that occur during normal physical activity. By doing this during a specific test called transesophageal echocardiography (TEE), they hope to get a clearer picture of how severe the MR is, which can help guide treatment decisions.

To be eligible for the study, participants must be at least 18 years old and have been diagnosed with mitral regurgitation based on a previous heart ultrasound. However, certain patients will not be included, such as those with serious heart problems, unstable conditions, or specific health issues that could make the TEE unsafe. If you choose to participate, you can expect to receive the phenylephrine during the TEE, and researchers will monitor how it affects the severity of your mitral regurgitation. This study is currently recruiting participants, and it aims to improve the way doctors assess heart conditions to provide better care for patients.

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ALL

Eligibility criteria

• 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.