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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.
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.
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
443 Previous Clinical Trials
582,501 Total Patients Enrolled
Mario Garcia, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility 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.I have severe symptoms from poor blood flow in my limbs.I am 18 or older and have mitral regurgitation, scheduled for a TEE test.I have worsening heart failure symptoms.I have severe, untreated heart artery blockage.I have severe pulmonary hypertension.My blood pressure and heart rate are not stable.You are not fit for a transesophageal echocardiogram (TEE).I am currently experiencing unstable chest pain or have recently had a heart attack.I have a serious irregular heartbeat condition.I am at high risk for brain bleeding due to past strokes or other vascular issues.
Research Study Groups:
This trial has the following groups:- Group 1: Mydfrin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the common use for Mydfrin?
"Mydfrin is frequently given to patients suffering from bronchial congestion. However, this medication can also be used to mitigate sinus congestion, allergic rhinitis (disorder), and ocular inflammation."
Answered by AI
Are there any patients that have not yet been enrolled in this research project?
"Yes, this is an ongoing clinical trial that was first posted on December 1st 2020. The listing has been edited as recently as February 28th 2022 and indicates the need for 35 patients at a single location."
Answered by AI
Can you share any other studies that have used Mydfrin?
"As of right now, 29 clinical trials are ongoing that research Mydfrin. Out of those 29, 5 are in Phase 3. However, it should be noted that these trials aren't exclusive to New Haven, Connecticut as there are 39 locations conducting these studies across the United States."
Answered by AI
How many individuals are being observed in this experiment?
"The listing on clinicaltrials.gov affirms that this study is open for recruitment and has been since December 1st, 2020. The latest update was on February 28th, 2022. They are looking for a total of 35 individuals willing to participate across a single site."
Answered by AI
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