NCT04500899 · Montefiore Medical Center
Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
What this study is about
The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby given through a vein (IV) phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic profile and variation that occurs with normal physical activity.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations