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Phenylephrine for Mitral Valve Regurgitation

Phase 1 & 2

Recruiting

Led By Mario Garcia, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients with preexisting bradycardia (HR < 50) and heart blocks.

Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether using phenylephrine to increase afterload during transesophageal echocardiography can provide more accurate quantification of Mitral Regurgitation severity.

Who is the study for?

This trial is for adults over 18 with Mitral Regurgitation (MR) detected on an initial heart scan, who are fit for a more detailed heart scan called transesophageal echocardiography (TEE). People with unstable heart conditions, severe artery disease, recent strokes or high blood pressure aren't eligible.

What is being tested?

The study tests the use of Mydfrin (phenylephrine) during TEE to increase afterload and mimic normal physical stress. This aims to better assess MR severity by observing changes in its grade under these simulated conditions, which could improve clinical decisions.

What are the potential side effects?

Potential side effects from phenylephrine may include increased blood pressure, irregular heartbeat, headache, dizziness, and possibly nausea. It's important to monitor patients closely for any adverse reactions during the procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a slow heartbeat (below 50 beats per minute) or heart block.

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My blood pressure is not higher than 150/90 mmHg.

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My blood pressure is not above 100 mmHg and I don't have severe heart valve leakage.

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I have severe symptoms from poor blood flow in my limbs.

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I have worsening heart failure symptoms.

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I have severe, untreated heart artery blockage.

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I have severe pulmonary hypertension.

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My blood pressure and heart rate are not stable.

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I am currently experiencing unstable chest pain or have recently had a heart attack.

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I have a serious irregular heartbeat condition.

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I am at high risk for brain bleeding due to past strokes or other vascular issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MydfrinExperimental Treatment1 Intervention

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.

0 / 11Eligibility criteria met