Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Part of paid clinical trials in New York, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT04500899
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mydfrin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterNew YorkNew York10470
Mario Garcia, MD

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