Recruiting
Phase 1
Phase 2

Phenylephrine

Sponsor:

Montefiore Medical Center

Code:

NCT04500899

Conditions

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mydfrin

Study Details

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.

Conditions

Mitral Regurgitation

Study ID

NCT04500899

Start date

Dec 1, 2020

Status verified date

Jul, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Mydfrin

Phenylephrine is available as phenylephrine hydrochloride injection, 10 mg/mL in 1 mL vial. For intravascular bolus administration, the investigators will prepare a solution containing 100 mcg/mL of phenylephrine hydrochloride, by withdrawing 10 mg (1ml of 10mg/mL) of phenylephrine injection and diluting with 99 mL of 5% dextrose injection or 0.9% sodium chloride injection.

Interventions

Mydfrin

A test dose of 20 mcg of Mydfrin will be administered through the peripheral intravenous line. BP will be monitored after each bolus of phenylephrine. Subsequent Mydfrin injections will then be administered in 50 mcg aliquots every 10-15 minutes, instead of 40 mcg, until the mean arterial blood pressure (MAP) increases by ≥ 20 mm Hg from the baseline MAP, however making sure not to exceed a MAP of 100 mmHg. Once a desired blood pressure has been achieved and maintained, echocardiographic evaluation of mitral regurgitation would be performed.

Primary outcome measure

  • The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography. [ Time Frame: Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes ]

Central Contacts and Locations

Central contacts

Mario Garcia, MD

718-920-4172mariogar@montefiore.org

Waqas Hanif, MD

646-270-1421whanif@montefiore.org

Locations

Montefiore Medical Center

Recruiting

New York, New York, United States, 10470

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-07-20.