RECRUITING

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography

Quick Facts

Study Start:2020-12-01

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04500899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.

Inclusion Criteria

Exclusion 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:
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.

Contacts and Locations

Study Contact

Mario Garcia, MD

CONTACT

718-920-4172

mariogar@montefiore.org

Waqas Hanif, MD

CONTACT

646-270-1421

whanif@montefiore.org

Principal Investigator

Mario Garcia, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center

New York, New York, 10470

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Mario Garcia, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01

Study Completion Date2025-06

Study Record Updates

Study Start Date2020-12-01

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Mitral Regurgitation