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New treatment option for Mitral Regurgitation
Official title Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
ClinicalTrials.gov ID: NCT04500899
What this study is testing
What is Mydfrin?
Mydfrin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mitral regurgitation.
Also referred to as Phenylephrine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral...
You likely can't join if
- The following patients will be excluded from the study:
- Patients who are not clinically eligible for TEE.
- Patients with contraindications to esophageal intubation.
- Patients with hemodynamic instability.
- Patients with acute decompensated heart failure (HF).
- Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease).
See the full eligibility criteria
- Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.
- The following patients will be excluded from the study:
- Patients who are not clinically eligible for TEE.
- Patients with contraindications to esophageal intubation.
- Patients with hemodynamic instability.
- Patients with acute decompensated heart failure (HF).
- Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease).
- Patients with ongoing unstable angina or ongoing myocardial infarction (MI)
- Patients with significant arrhythmias including atrial fibrillation.
- Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg).
- Patients with preexisting bradycardia (HR \< 50) and heart blocks.
- Patients with severe symptomatic peripheral vascular disease.
- Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure sPAP ≥ 60mm Hg).
- Patients who are at high risk for intracranial bleeding such as patients with previous strokes, transient ischemic attack (TIA) and vascular malformations.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.