Back to results

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Primary Purpose

Mitral Regurgitation

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Mydfrin

About this trial

This is an interventional diagnostic trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mydfrin

Arm Description

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.

Outcomes

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.

The purpose of this study is to compare the echocardiographic parameters of MR grade before and after the use of phenylephrine during transesophageal echocardiography (TEE) and to document an increase in echocardiographic parameters of MR grade after the use of phenylephrine.

Secondary Outcome Measures

Full Information

NCT ID

NCT04500899

First Posted

July 23, 2020

Last Updated

July 18, 2023

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04500899

Brief Title

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Official Title

Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

Routine echocardiography which is used to assess the severity of mitral regurgitation, sometimes underestimates the severity of mitral regurgitation, due to hemodynamic variations that occurs with normal physical activity and under the effect of sedation which is used to perform transesophageal echocardiography. By using phenylephrine during transesophageal echocardiography, the study intends to offset the hemodynamic variation that occurs with sedation and better assess the severity of mitral regurgitation, which would further assist in clinical decision-making regarding treatment. The goal of this study is to compare the severity of mitral regurgitation grade before and after the administration of phenylephrine during transesophageal echocardiography and to demonstrate a 25% increase in severity of mitral regurgitation grade compared to the baseline conditions, following the administration of phenylephrine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Regurgitation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mydfrin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Mydfrin

Other Intervention Name(s)

Phenylephrine

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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 and excluded from the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Safeera Javed, MD

Phone

929-293-6103

safeerajaved@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Waqas Hanif, MD

Phone

646-270-1421

whanif@montefiore.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario Garcia, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10470

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mario Garcia, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18652937

Citation

Carabello BA. The current therapy for mitral regurgitation. J Am Coll Cardiol. 2008 Jul 29;52(5):319-26. doi: 10.1016/j.jacc.2008.02.084.

Results Reference

background

PubMed Identifier

1596042

Citation

Lehmann KG, Francis CK, Dodge HT. Mitral regurgitation in early myocardial infarction. Incidence, clinical detection, and prognostic implications. TIMI Study Group. Ann Intern Med. 1992 Jul 1;117(1):10-7. doi: 10.7326/0003-4819-117-1-10. Erratum In: Ann Intern Med 1992 Aug 15;117(4):349.

Results Reference

background

PubMed Identifier

10190406

Citation

Singh JP, Evans JC, Levy D, Larson MG, Freed LA, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999 Mar 15;83(6):897-902. doi: 10.1016/s0002-9149(98)01064-9. Erratum In: Am J Cardiol 1999 Nov 1;84(9):1143.

Results Reference

background

PubMed Identifier

28315732

Citation

Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.

Results Reference

background

PubMed Identifier

17543738

Citation

Shiran A, Merdler A, Ismir E, Ammar R, Zlotnick AY, Aravot D, Lazarovici H, Zisman E, Pizov R, Lewis BS. Intraoperative transesophageal echocardiography using a quantitative dynamic loading test for the evaluation of ischemic mitral regurgitation. J Am Soc Echocardiogr. 2007 Jun;20(6):690-7. doi: 10.1016/j.echo.2006.11.004.

Results Reference

background

PubMed Identifier

28506541

Citation

Sanfilippo F, Johnson C, Bellavia D, Morsolini M, Romano G, Santonocito C, Centineo L, Pastore F, Pilato M, Arcadipane A. Mitral Regurgitation Grading in the Operating Room: A Systematic Review and Meta-analysis Comparing Preoperative and Intraoperative Assessments During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Oct;31(5):1681-1691. doi: 10.1053/j.jvca.2017.02.046. Epub 2017 Feb 13.

Results Reference

background

PubMed Identifier

9509352

Citation

Kolev N, Brase R, Wolner E, Zimpfer M. Quantification of mitral regurgitant flow using proximal isovelocity surface area method: a transesophageal echocardiography perioperative study. J Cardiothorac Vasc Anesth. 1998 Feb;12(1):22-6. doi: 10.1016/s1053-0770(98)90050-7.

Results Reference

background

PubMed Identifier

1991377

Citation

Recusani F, Bargiggia GS, Yoganathan AP, Raisaro A, Valdes-Cruz LM, Sung HW, Bertucci C, Gallati M, Moises VA, Simpson IA, et al. A new method for quantification of regurgitant flow rate using color Doppler flow imaging of the flow convergence region proximal to a discrete orifice. An in vitro study. Circulation. 1991 Feb;83(2):594-604. doi: 10.1161/01.cir.83.2.594.

Results Reference

background

Learn more about this trial

Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

We'll reach out to this number within 24 hrs