Mitral Regurgitation Clinical Trial
Official title:
Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography
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.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes |
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 |
NCT06167213 -
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
|
N/A | |
Not yet recruiting |
NCT06465745 -
AltaValve Pivotal Trial
|
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 |
NCT05836532 -
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
|
||
Completed |
NCT05836480 -
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
|
||
Completed |
NCT05850026 -
Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
|
||
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 |