The history and tradition for heart and vascular care on the Baylor Dallas campus is rich with many examples of innovation and research involvement. Conducted through the Baylor Scott & White Heart and Vascular Institute and Soltero Cardiovascular Research Center, research involves new treatment options for heart and vascular patients. Physicians and executive leadership at Baylor Scott & White Heart and Vascular Hospital – Dallas strengthened their resolve to keep research at the heart of ongoing efforts to improve the diagnosis, treatment and care for patients with cardiac and vascular disease.
The Baylor Scott & White Heart and Vascular Institute was established in 1993 to promote cardiovascular research and education to prevent and treat heart and vascular disease. Serves as a research and education facility that supports development and implementation of the newest techniques and technologies in cardiovascular care. Baylor Scott & White Heart and Vascular Institute is part of Baylor University Medical Center and does not provide a referral service.
The Soltero Cardiovascular Research Center began at Baylor-Dallas in 1987 to bring clinically relevant cardiology research studies to Baylor Scott & White Health. The Center is improving patients' lives through innovative research to understand, prevent, and even reverse heart disease. The Center is nationally recognized for conducting high-quality studies on cardiovascular problems, medications, and surgical procedures.
Purpose of the research:
To establish the safety and effectiveness of the WATCHMAN Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are not suitable for oral
anticoagulation therapy.
Inclusion:
Exclusion
Primary Investigator: James Choi, MD
Who to contact for more info: Jennifer Cruthis 214-820-3319 jennifer.cruthis@bswhealth.org .
Learn more about the study
MB001-067 A PROSPECTIVE, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, RANDOMIZED TRIAL OF EXTENDED RELEASE EXENATIDE VERSUS PLACEBO IN DIABETIC
PATIENTS WITH TYPE 4 CARDIORENAL SYNDROME (EXTEND-CRS TRIAL) AMENDMENT 1.
The purpose of the this research study is to find what effects BYDUREON® (EXENATIDE EXTENDED-RELEASE FOR INJECTABLE SUSPENSION)®, a currently FDA approved treatment for type 2 diabetes
mellitus, has on heart and kidney function.
Inclusion
Exclusion
Principle Investigator: Peter McCullough, MD
For more information regarding enrollment of this trial, please contact Patrice Perryman at Patrice.Perryman@BSWHealth.org.
QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery (QUARK 309)
A randomized, double-blind, placebo-controlled, Phase 3 trial evaluate QPI-1002 versus placebo for the prevention of major adverse kidney events in patients at high risk for acute
kidney injury following cardiac surgery.
Principle Investigator: Robert F. Hebeler, MD
Type of study: Interventional
Study Synopsis
This randomized, double-blind, placebo-controlled, Phase 3 trial evaluate QPI-1002 versus placebo for the prevention of major adverse kidney events in patients at high risk for acute kidney
injury following cardiac surgery. Patients will be given doses of QPI-1002 or placebo after the completion of cardiovascular surgery. The study will look at the following outcomes metrics:
proportion of patients through day 90 who develop major adverse kidney events; proportion of patients developing AKI overall by modified AKIN criteria within five days post-surgery; renal
function as estimated by glomerular filtration rate; proportion of subjects who die or initiate dialysis through day 90.
“Acute kidney injury is a fairly frequent occurrence after open heart surgery and can be anywhere from mild to severe with long-term adverse consequences to the patient. The QUARK study
examines an agent researchers believe could prevent specific kidney injury following coronary artery bypass. This is a Phase 3 trial with the first two studies producing promising outcomes.”
Robert Hebeler, MD, principal investigator.
Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria for the reduced ejection fraction study can be found at
https://www.clinicaltrials.gov/ct2/show/NCT03510897?term=QUARK+309&rank=1
Study contact:
For more information regarding enrollment of this trial, please contact Merielle Boatman, MBA, BAAS, Merielle.Boatman@BSWHealth.org, 214.820.2273.
To identify the optimal dose of aspirin for secondary prevention in patients with atherosclerotic cardiovascular disease (ASCVD).
Purpose of the trial: Millions of Americans who have heart disease already take either regular (325 mg) or low-dose (81 mg) aspirin. Even though both doses of aspirin are widely used,
no one knows which is better. The goal of ADAPTABLE is to try to find out which dose of aspirin is better for cardiovascular patients.
Inclusion
1. Age =18
2. Known atherosclerotic cardiovascular disease (ASCVD), defined as ANY of the following:
a. Prior myocardial infarction
b. Prior coronary revascularization procedures (either prior PCI or prior CABG)
c. Prior coronary angiography showing =75% stenosis of at least one epicardial coronary vessel
d. History of chronic ischemic heart disease, coronary artery disease, or atherosclerotic cardiovascular disease
3. No known safety concerns or side effects considered to be related to aspirin
4. Not currently treated with an oral anticoagulant—either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban)—and not planned to be treated in the future
with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
Exclusion
There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of
randomization, or are planned to be used during the study follow-up.
Who to contact for more information:
Sharla Russell Sharla.Russell@BSWHealth.org
A registry to assess outcomes using a catheter-mounted, LVAD-like device for PCI.
Primary investigator: Robert Stoler, MD
Who to contact for more information:
Emily Laible, RN, BSN, CCRC, at 214-820-9903
A Double-Blind, Randomized, Sham-Procedure-Controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in
Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology:
DREAM HF-1.
Primary Investigator: Cara East, MD
For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273
Learn more about the study
Summary: A Phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). Empagliflozin outcome trial in patients with chronic heart failure (EMPEROR-Preserved)
Primary Investigator: Cara East, MD, Peter A. McCullough, MD.
For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273
A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF). Empagliflozin outcome trial in patients with chronic heart failure (EMPEROR-Reduced)
Primary Investigator: Cara East, MD, Peter A. McCullough, MD.
For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273
The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF. Inclusion:
GUIDE-HF - Hemodynamic-Guided Management of Heart Failure is a study to evaluate heart failure patients with a recent heart failure hospitalizations and NYHA II or III or IV and
the effectiveness of the CardioMEMS HF System device.
Inclusion Criteria:
HEART-FID - Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of
participants in heart failure with iron deficiency and with a reduced ejection fraction. The placebo-controlled study assesses the effects of IV FCM compared to placebo on the 12-month rate
of death, hospitalization for worsening heart failure, and the six-month change in six minute walk test (6MWT) for patients in heart failure with iron deficiency.
Principal Investigator: Shelley Hall, MD, FACC, FHFSA
For more information about this study, please contact Amanda Doss at Amanda.Doss@BSWHealth.org or 214.865.2419.
The study will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than a standard dose quadrivalent influenza vaccine
in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure.
Inclusion:
The purpose of this is to evaluate the safety and effectiveness of the HeartMate III LVAS by demonstrating non-inferiority to the HeartMate II LVAS when used for
the treatment of advanced, refractory, left ventricular heart failure.
Inclusion Criteria
Exclusion
Principle Investigator: Shelley Hall, MD
For more information regarding enrollment of this trial, please contact Horacio Martinez at Horacio.Martinez@BSWHealth.org.
A multi-center, randomized, double-blind, active-controlled study to evaluate the effects of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction.
Primary Investigator: Cara East, MD
For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273
The purpose of the Reduce LAP-HF study is to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart
Failure. The Corvia Medical InterAtrial Shunt Device (IASD®) System II is indicated for the improvement in quality of life and reduction of heart failure related symptoms and events in
patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard GDMT.
Inclusion Criteria:
Purpose of the study: evaluates the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension
(PH) after left ventricular assist device implantation. The study also evaluates the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity
in subjects with PH after LVAD implantation. Finally, the study explores the potential effect of macitentan 10 mg as compared to placebo on right ventricular function, selected clinical
events, and on renal function as measured by glomerular filtration rate (GFR), in subjects with PH after LVAD implantation.
Principal investigator: Shelley Hall, MD, FACC, FHFSA
For more information including inclusion and exclusion criteria, contact Amanda Doss at Amanda.Doss@bswhealth.org or 214.865.2419.
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven trial of MK-1242 (vericiguat) in subjects with heart
failure with reduced ejection fraction (HFrEF)
Purpose of the trial: The purpose of this study is to:
Inclusion
1. Have a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying
HF decompensation.
2. Have a left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior
to randomization.
3. Have brain natriuretic peptide (BNP) prior to randomization as follows:
Exclusion
1. Has concurrent or anticipated use of long-acting nitrates or NO donors including isosorbide dinitrate, isosorbide 5-mononitrate, entaerythritol tetranitrate, nicorandil or
transdermal nitroglycerin (NTG) patch, and molsidomine.
2. Has concurrent use or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.
3. Has symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days prior to randomization.
4. Has acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy.
5. Is awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates
receiving an implanted ventricular assist device.
Principle Investigator:Peter McCullough, MD, MPH
Who to contact for more information:
Laura Clariday Laura.Clariday@BSWHealth.org
Learn more about the study
The purpose of this randomized controlled trial is to evaluate the safety and effectiveness of the Amulet device versus the commercially available Boston Scientific LAA closure (LAAC) device in subjects with non-valvular atrial fibrillation. The trial will test whether the device meaningfully improves health outcomes of all enrolled subjects through evaluation of the safety and effectiveness.
Inclusion
1. 18 years of age or older
2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
3. At high risk of stroke or systemic embolism defined as CHADS2 score >2 or a CHA2DS2-VASc score of >3
4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making
(see inclusion criteria #6)
6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared
decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record)
7. Able to comply with the required medication regimen post-device implant
8. Able to understand and willing to provide written informed consent to participate in the trial
9. Able to and willing to return for required follow-up visits and examinations
Exclusion
Please contact the research coordinator, Theresa Cheyne, at 817-922-2579.
Principle Investigator for Fort Worth site: Craig Delaughter, MD, PhD, FACC, FHRS
Who to contact for more information:
Theresa Cheyne (Office 817-922-2579)
Theresa.cheyne@bswhealth.org
The STOP Persistent AF trial is currently enrolling participants to study the safety and efficacy of a dry-balloon device in those with recurrent, symptomatic
atrial fibrillation (AFib) that has not been controlled by medication.
Inclusion:
Exclusion: Contact research coordinator, Cathy Headley, RN, 214.820.7108 or email Cathy.Headley@bswhealth.org.
Investigators: Peter Wells, MD and Kevin Wheelan, MD
For more information, contact research coordinator, Cathy Headley, RN at 214.820.7108 or email Cathy.Headley@bswhealth.org.
Purpose of the retrospective study VELOXIS: This is a Phase II study evaluating the efficacy of tacrolimus extended release tablets to twice daily tacrolimus
dosing regimen. Twenty-five adult recipients of a heart transplant will be enrolled in each group – one receiving a once a day dosing of Envarsus, the other receiving twice a day dosing of
Prograf. Results of the two groups will be compared and evaluated for short term safety and tolerability of Envarsus. A follow-up safety assessment may be administered to follow up on any
safety issues identified.
Principal Investigator: Shelley Hall, MD, FACC, FHFSA
For complete inclusion and exclusion criteria, please contact the study coordinators:
Amanda Doss, BS, CHES, Amanda.Doss@bswhealth.org, 214.865.2419 or
Michelle Clark, RN, Donna.Clark1@bswhealth.org, 214.820.1685.
Purpose:
The registry is designed to evaluate the long-term safety and effectiveness of the medication lomitapide in clinical practice for patients with homozygous familial hypercholesterolemia.
Inclusion Criteria:
Exclusion Criteria:
Primary Investigator: Peter McCullough, MD, MPH
Contact: Research Coordinator Laura Clariday Laura.Clariday@BSWHealth.org
Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in Patients with uncontrolled Hypertension in the Absence of Antihypertensive medications: SPYRAL Study.
Primary Investigator: James W. Choi, MD Sub-Investigator: Cara East, MD
For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273
This study is designed to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.
Inclusion:Principal investigator: Cara East, MD, Medical Director, Soltero Cardiovascular Research Center
For more information regarding enrollment in this trial, please contact Merielle Boatman, at Merielle.Boatman@BSWHealth.org.
Study to evaluate whether TMVR is non-inferior to conventional mitral valve surgery at one year for patients with severe symptomatic native mitral regurgitation. A multi-center, global, prospective, randomized, interventional pre-market trial, Apollo study subjects were randomized on a 1:1 basis to either TMVR with the Medtronic Intrepid™ TMVR System or to conventional mitral valve surgery to compare treatment efficacy.
Inclusion
To participate in this trial, the subject must meet ALL the following inclusion criteria.
1. Subject has severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards – Recommendations for Non-invasive Evaluation of
Native Valvular Regurgitation
2. Heart Team agrees that patient is a candidate for bioprosthetic mitral valve replacement
3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
Exclusions: There is a long list of exclusions. Please contact the research coordinator for additional information. Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org
Primary Investigator: Ravi Vallabhan, MD, FACC
For more information contact:
Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org
Learn more about the study
This study evaluates the procedural safety and efficacy of the Medtronic TAVR system on inpatients with bicuspid aortic anatomy and severe aortic stenosis at low
risk for SAVR. Dallas location is the only Dallas area site with access for this trial.
Inclusion criteria:
This is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System in de novo, calcified, stenotic, coronary arteries prior to stenting.
Inclusions/Exclusions:
Please contact the research coordinator for the exclusions: Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.
Additional information may be found for this study, DISRUPT CAD III, at: https://www.clinicaltrials.gov/ct2/show/NCT03595176?term=DISRUPT+CAD+III+STUDY&rank=1
Primary Investigator:
Robert M. Stoler, MD, FACC, FSCAI
For more information, please contact: Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.
Learn more about the study
A prospective, controlled, multi-center study; patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance (CS). Patients will be stratified by whether or not they are able to perform a treadmill stress test; in addition, patients who are screened for enrollment but have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
Inclusion
Patients must meet the following inclusion criteria to be included in the trial:
1. 65 years of age or older at time of randomization
2. Severe aortic stenosis defined as:
3. Patient is asymptomatic defined as:
1) Negative treadmill stress test. To be considered asymptomatic, the patient must not demonstrate any of the following during and/or after the test:
Limiting dyspnea or decreased exercise tolerance, defined as inability to reach 60% of age and sex adjusted metabolic equivalents of task (METs)
OR
2) Per physician after thorough assessment of patient history if the patient is unable to perform a stress test.
4. LV ejection fraction =50%
5. Society of Thoracic Surgeons (STS) risk score =10
6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the
respective clinical site
Exclusions: Please contact the research coordinator for the exclusions: Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.
Primary Investigator: Robert M. Stoler, MD, FACC, FSCAI
For more information, please contact:
Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.
A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk
Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement.
This study’s objective is to establish the safety and effectiveness of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic,
severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement(SAVR).
Inclusion:
Primary Investigator: Robert Stoler, MD, FACC, FSCAI
For more information contact Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org
TAVR with Medtronic TAVR with Medtronic TAVR System in Patients with Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality
with Surgical Aortic Valve Replacement (SAVR).
This study’s objective is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic
stenosis at low risk for SAVR.
Inclusion:
Primary Investigator: Robert Stoler, MD, FACC, FSCAI
For more information contact Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral
Regurgitation (SUMMIT).
Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation.
Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site heart team. Subjects must satisfy the trial inclusion/exclusion criteria and be
approved by the Subject Eligibility Committee (SEC), prior to inclusion in the trial.
Surgical arm: Subjects whom the local site heart team determines are appropriate for mitral valve surgery will be randomized in a 2:1 ratio to the Tendyne device (Treatment
group) or to standard of care surgical repair or total chordal-sparing surgical replacement (Control group). Randomization will be stratified by investigational site.
Non-surgical arm: Subjects whom the local site heart team determines are not appropriate for mitral valve surgery and whose valve anatomy is not suitable
for transcatheter repair, will be eligible to enroll into the non-surgical arm in which all subjects will receive the Tendyne device.
Primary Investigator: Paul Grayburn, MD
For more information, please contact: Susan Aston, RN 214.820.7358
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