Clinical trial

Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography

Name

2020-11414

Description

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.

Trial arms

Trial start

2020-12-01

Estimated PCD

2024-06-01

Trial end

2024-06-01

Status

Recruiting

Phase

Early phase I

Treatment

Mydfrin

A test dose of 20 mcg of Mydfrin will be administered through the peripheral intravenous line. Subsequent Mydfrin injections will then be administered in 40 mcg aliquots every 10-15 minutes, 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.

Arms:

Mydfrin

Other names:

Phenylephrine

Size

Primary endpoint

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

Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes

Eligibility criteria

Inclusion Criteria: * Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation. Exclusion Criteria: * The following patients will be excluded from the study: 1. Patients who are not clinically eligible for TEE. 2. Patients with contraindications to esophageal intubation. 3. Patients with hemodynamic instability. 4. Patients with acute decompensated heart failure (HF). 5. Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease). 6. Patients with ongoing unstable angina or ongoing myocardial infarction (MI) 7. Patients with significant arrhythmias including atrial fibrillation. 8. Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg). 9. Patients with preexisting bradycardia (HR \< 50) and heart blocks. 10. Patients with severe symptomatic peripheral vascular disease. 11. Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure sPAP ≥ 60mm Hg). 12. Patients who are at high risk for intracranial bleeding such as patients with previous strokes, transient ischemic attack (TIA) and vascular malformations. 13. 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 and excluded from the study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ESTIMATED'}}

Updated at

2023-07-19

1 organization

1 product

1 indication

Organization

Montefiore Medical Center

Product

Mydfrin

Indication

Mitral Valve Regurgitation