Status:
RECRUITING
Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 mimi...
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 nor...
Eligibility Criteria
Inclusion
- Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04500899
Start Date
December 1 2020
End Date
June 1 2026
Last Update
July 20 2025
Active Locations (1)
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1
Montefiore Medical Center
New York, New York, United States, 10470