Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04500899
Study type	Interventional
Source	Montefiore Medical Center
Contact	Safeera Javed, MD
Phone	929-293-6103
Email	safeerajaved@gmail.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	December 1, 2020
Completion date	June 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03278574` - Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease	N/A
Suspended	`NCT04960280` - A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease	N/A
Recruiting	`NCT05021614` - Valveclip® Transcatheter Mitral Valve Repair Study	N/A
Not yet recruiting	`NCT06465745` - AltaValve Pivotal Trial	N/A
Not yet recruiting	`NCT06167213` - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral	N/A
Withdrawn	`NCT05040451` - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn	`NCT03714412` - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System	N/A
Recruiting	`NCT02592889` - (MitraClip in Non-Responders to Cardiac Resynchronization Therapy)	Phase 4
Completed	`NCT02355418` - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Not yet recruiting	`NCT01431222` - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery	Phase 4
Completed	`NCT01841554` - Cardioband With Transfemoral Delivery System	N/A
Not yet recruiting	`NCT03870516` - Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery	N/A
Active, not recruiting	`NCT03230747` - SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation	N/A
Enrolling by invitation	`NCT04031274` - Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
Completed	`NCT05850026` - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Completed	`NCT05836480` - Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Completed	`NCT05836532` - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Recruiting	`NCT03975998` - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed	`NCT01162083` - Identifying an Ideal Cardiopulmonary Exercise Test Parameter	N/A
Suspended	`NCT00787293` - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients	Phase 2