35 Participants Needed

Phenylephrine for Mitral Valve Regurgitation

SJ
WH
MG
Overseen ByMario Garcia, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Montefiore Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Phenylephrine for Mitral Valve Regurgitation?

The research does not provide direct evidence for the effectiveness of Phenylephrine in treating Mitral Valve Regurgitation. However, one case report mentions the use of Phenylephrine to maintain stable cardiovascular parameters during mitral valve surgery, suggesting it may help manage blood pressure in this context.12345

Is phenylephrine generally safe for humans?

Phenylephrine is generally considered safe for humans, but it can cause rare allergic reactions and should be used cautiously in people with high blood pressure. It has a good safety record when used as a nasal decongestant.678910

How does phenylephrine differ from other drugs for mitral valve regurgitation?

Phenylephrine is unique in its use for mitral valve regurgitation as it is primarily a vasoconstrictor, which helps maintain blood pressure during surgery, unlike other treatments like milrinone that focus on vasodilation and increasing cardiac output.35111213

Research Team

MG

Mario Garcia, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older and have mitral regurgitation, scheduled for a TEE test.

Exclusion Criteria

I have a slow heartbeat (below 50 beats per minute) or heart block.
My blood pressure is not higher than 150/90 mmHg.
My blood pressure is not above 100 mmHg and I don't have severe heart valve leakage.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Administration of phenylephrine during transesophageal echocardiography to assess mitral regurgitation severity

40 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Phenylephrine
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

Findings from Research

In a study of 25 patients undergoing mitral valve surgery, enoximone was found to be a highly effective first-line inotropic agent, successfully weaning all patients from cardiopulmonary bypass with significant improvements in cardiac index and stroke index without increasing heart rate.
Compared to dobutamine and dopamine, enoximone demonstrated superior hemodynamic effects, with fewer patients experiencing inadequate responses, highlighting its advantages in managing post-operative low output states.
Haemodynamic effects and comparison of enoximone, dobutamine and dopamine following mitral valve surgery.Tarr, TJ., Moore, NA., Frazer, RS., et al.[2013]
In a study of five patients with severe pulmonary hypertension and right heart failure after mitral valve replacement, high-dose prostaglandin E1 effectively reduced pulmonary vasoconstriction and improved right ventricular function.
The combination of prostaglandin E1 with norepinephrine helped maintain blood pressure while enhancing pulmonary vasodilation, leading to successful recovery without any cases of right ventricular infarction or chronic heart failure post-surgery.
Prostaglandin E1. A new therapy for refractory right heart failure and pulmonary hypertension after mitral valve replacement.D'Ambra, MN., LaRaia, PJ., Philbin, DM., et al.[2013]
In a case study of a 58-year-old woman with mitral regurgitation undergoing valve repair or replacement, careful anesthetic management was crucial, involving graded induction and the use of medications like isoflurane and phenylephrine to maintain stable cardiovascular parameters.
Milrinone was effectively used for inotropic support due to its vasodilator properties, which helped improve blood flow while minimizing pulmonary hypertension, highlighting the importance of tailored anesthetic strategies in patients with mitral regurgitation.
Mitral valve replacement: a case report.Reckard, D., Cipcic, E., Mackin, C.[2012]

References

Haemodynamic effects and comparison of enoximone, dobutamine and dopamine following mitral valve surgery. [2013]
Prostaglandin E1. A new therapy for refractory right heart failure and pulmonary hypertension after mitral valve replacement. [2013]
Mitral valve replacement: a case report. [2012]
[Comparison of the hemodynamic effects of dobutamine and enoximone in the treatment of low cardiac output after valvular surgery]. [2013]
Effects of phosphodiesterase inhibitors after coronary artery bypass grafting. [2019]
Type IV reaction due to phenylephrine administered nasally with cross-reactivity with ethylephrine. [2013]
Erythrodermia to pseudoephedrine in a patient with contact allergy to phenylephrine. [2019]
Are oral decongestants safe in hypertension? An evaluation of the evidence and a framework for assessing clinical trials. [2013]
Substitution of phenylephrine for pseudoephedrine as a nasal decongeststant. An illogical way to control methamphetamine abuse. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Pseudoephedrine producing postural hypotension in a pilot. [2013]
[The use of milrinone in a patient with mitral regurgitation and severe pulmonary hypertension: a case report]. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Effects of milrinone on contractile responses of guinea pig trachea, lung parenchyma and pulmonary artery. [2015]
Comparing the effects of milrinone and olprinone in patients with congestive heart failure. [2020]