NCT04500899 Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
| NCT ID | NCT04500899 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Montefiore Medical Center |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2020-12-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Mario Garcia, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT04500899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04500899 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04500899 currently recruiting?
Yes, NCT04500899 is actively recruiting participants. Contact the research team at mariogar@montefiore.org for enrollment information.
Where is the NCT04500899 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04500899 clinical trial?
NCT04500899 is sponsored by Montefiore Medical Center. The principal investigator is Mario Garcia, MD at Montefiore Medical Center. The trial plans to enroll 35 participants.