Study Summary
This trial will test whether using phenylephrine to increase afterload during transesophageal echocardiography can provide more accurate quantification of Mitral Regurgitation severity.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes
Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes
The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Mydfrin
1 of 1
Experimental Treatment
35 Total Participants · 1 Treatment Group
Primary Treatment: Mydfrin · No Placebo Group · Phase 1 & 2
Mydfrin
Drug
Experimental Group · 1 Intervention: Mydfrin · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
414 Previous Clinical Trials
554,870 Total Patients Enrolled
Mario Garcia, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Carabello, Blase A.. 2008. “The Current Therapy for Mitral Regurgitation”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2008.02.084.
- Kolev, Nikolai, Rainer Brase, Ernst Wolner, and Michael Zimpfer. 1998. “Quantification of Mitral Regurgitant Flow Using Proximal Isovelocity Surface Area Method: A Transesophageal Echocardiography Perioperative Study”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1016/s1053-0770(98)90050-7.
- Shiran, Avinoam, Amnon Merdler, Ehab Ismir, Rony Ammar, Amnon Y. Zlotnick, Dan Aravot, Horia Lazarovici, Eli Zisman, Reuven Pizov, and Basil S. Lewis. 2007. “Intraoperative Transesophageal Echocardiography Using a Quantitative Dynamic Loading Test for the Evaluation of Ischemic Mitral Regurgitation”. Journal of the American Society of Echocardiography. Elsevier BV. doi:10.1016/j.echo.2006.11.004.
- Recusani, F, G S Bargiggia, A P Yoganathan, A Raisaro, L M Valdes-Cruz, H W Sung, C Bertucci, M Gallati, V A Moises, and I A Simpson. 1991. “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. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.cir.83.2.594.
- Lehmann, Kenneth G.. 1992. “Mitral Regurgitation in Early Myocardial Infarction”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-117-1-10.
- Singh, Jagmeet P, Jane C Evans, Daniel Levy, Martin G Larson, Lisa A Freed, Deborah L Fuller, Birgitta Lehman, and Emelia J Benjamin. 1999. “Prevalence and Clinical Determinants of Mitral, Tricuspid, and Aortic Regurgitation (the Framingham Heart Study)”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/s0002-9149(98)01064-9.
- Nishimura, Rick A., Catherine M. Otto, Robert O. Bonow, Blase A. Carabello, John P. Erwin III, Lee A. Fleisher, Hani Jneid, et al.. 2017. “2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2017.03.011.
- Sanfilippo, Filippo, Christopher Johnson, Diego Bellavia, Marco Morsolini, Giuseppe Romano, Cristina Santonocito, Luigi Centineo, Federico Pastore, Michele Pilato, and Antonio Arcadipane. 2017. “Mitral Regurgitation Grading in the Operating Room: A Systematic Review and Meta-analysis Comparing Preoperative and Intraoperative Assessments During Cardiac Surgery”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2017.02.046.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2020. "Use of Phenylephrine for Assessment of Mitral Regurgitation Severity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04500899.
Frequently Asked Questions
What is the common use for Mydfrin?
"Mydfrin is frequently given to patients suffering from bronchial congestion. However, this medication can also be used to mitigate sinus congestion, allergic rhinitis (disorder), and ocular inflammation." - Anonymous Online Contributor
Unverified Answer
Are there any patients that have not yet been enrolled in this research project?
"Yes, this is an ongoing clinical trial that was first posted on December 1st 2020. The listing has been edited as recently as February 28th 2022 and indicates the need for 35 patients at a single location." - Anonymous Online Contributor
Unverified Answer
Can you share any other studies that have used Mydfrin?
"As of right now, 29 clinical trials are ongoing that research Mydfrin. Out of those 29, 5 are in Phase 3. However, it should be noted that these trials aren't exclusive to New Haven, Connecticut as there are 39 locations conducting these studies across the United States." - Anonymous Online Contributor
Unverified Answer
How many individuals are being observed in this experiment?
"The listing on clinicaltrials.gov affirms that this study is open for recruitment and has been since December 1st, 2020. The latest update was on February 28th, 2022. They are looking for a total of 35 individuals willing to participate across a single site." - Anonymous Online Contributor
Unverified Answer