Clinical Trials

EXTEND

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

• Age ≥18
• Type 2 diabetes mellitus with hemoglobin A1c 6.6 – 9.9 % with or without the use of insulin

Exclusion

• Allergy to gadolinium or gadodiamide
• Implanted metallic device

Principle Investigator: Peter McCullough, MD

For more information regarding enrollment of this trial, please contact Patrice Perryman at Patrice.Perryman@BSWHealth.org.

SPYRAL OFF MED

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

ADAPTABLE

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:
Rebecca Baker, RN (Office 214-820-7965)

CVAD Trial

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

DREAM

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

EMPEROR-Preserved

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

EMPEROR-Reduced

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

MOMENTUM 3 IDE Clinical Study

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

• Age ≥18 years and inotrope dependent or on Optimal Medical Management (OMM) for at least 45 out of the last 60 days

Exclusion

• Presence of any risk factors of severe end organ dysfunction

Principle Investigator: Shelley Hall, MD

For more information regarding enrollment of this trial, please contact Natasia Weiss at Natasia.Weiss@BSWHealth.org.

PERSPECTIVE

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

Victoria

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:

• Test the safety of the study drug, MK-1242 (vericiguat).
• Test the efficacy effect of the MK-1242 (vericiguat) compared with placebo (dummy tablets), added to best usual treatment

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:

• BNP
• Sinus Rhythm ≥ 300 pg/mL
• Atrial Fibrillation ≥ 500 pg/mL

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:
Rebecca Baker, RN (Office 214-820-7965)

Amulet

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

STOP Persistent AF Clinical Trial

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:

• Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
• Failure or intolerance of at least one Class I or III antiarrhythmic drug
• Age 18 or older (or older than 18 if required by local law)

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.

CLEAR Study

A randomized, double-blind, placebo-controlled study to assess the effects of Bempedoic Acid (ETC-1002) on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease who are statin intolerant. (CDA completed)

Primary Investigator: Cara East, MD

For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273

Apollo

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, BSW, CCRC
214-820-9903

COAPT CAS

COAPT CAS is an extension of the COAPT Randomized Control Trial (RCT) under the same IDE as COAPT RCT.

After the enrollment of the COAPT RCT is complete, COAPT CAS will provide the opportunity to continue the evaluation of the safety and effectiveness of the MitraClip® NT System in patients who meet the COAPT inclusion/exclusion criteria. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more “real world” conditions. COAPT CAS will collect additional safety and effectiveness data to support the Premarket Approval (PMA) application of the labeling claims for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery.

Inclusion:

• Subjects who have national Medicare coverage by CMS
• Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology
• Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure
• Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
• Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject
• Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
• Left Ventricular End Systolic Dimension (LVESD) is ≤70mm

Exclusions: Contact research coordinator, Susan Aston, RN at 214-820-7358
Primary Investigator: Paul Grayburn, MD

Who to contact for more information: Susan Aston, RN 214-820-7358

Early TAVR

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:

• Aortic valve area (AVA) ≤1.0 cm2 or AVA index ≤0.6 cm2/m2 AND
• Peak jet velocity ≥4.0 m/s or Mean gradient ≥40 mmHg

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:

• Syncopal or pre-syncopal episode, including severe dizziness
• Angina

Limiting dyspnea or decreased exercise tolerance, defined as inability to reach 60% of age and sex adjusted metabolic equivalents of task (METs)

• Lack of increase or a drop in systolic blood pressure
• Significant ventricular arrhythmias (≥4 consecutive ventricular premature beats)

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: Rebecca Baker, RN, at 214-820-7965.
Primary Investigator: Robert M. Stoler, MD, FACC, FSCAI

For more information, please contact: Rebecca Baker, RN, at 214-820-7965.

Tendyne Bioprosthetic Mitral Valve System

The purpose of this expanded clinical study is to evaluate the performance and safety of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. The data gathered in this study may be used to support conformity requirements for CE Mark of the Tendyne system.

Inclusion
Please note: subjects must meet all of the following criteria:
1. Severe mitral regurgitation of primary or secondary etiology.
2. New York Heart Association (NYHA) functional Class ≥ II. If Class IV, patient must be ambulatory.
3. Heart team determines patient is not a suitable candidate for traditional surgical treatment.
4. Age 18 years or older.

Exclusions: Contact research coordinator, Susan Aston, RN at 214-820-7358
Primary Investigator: Paul Grayburn, MD

Who to contact for more information: Susan Aston, RN 214-820-7358

TWELVE

Study to determine safety and performance of The Twelve Intrepid™ Transcatheter Mitral Valve Replacement System in high risk patients with severe, symptomatic mitral regurgitation. The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of The Intrepid™ TMVR System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

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. Severe mitral regurgitation (MR Grade 3-4+)
2. Symptomatic mitral regurgitation (NYHA Class II-IV)
3. Deemed to be at high risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, and an echocardiologist)
4. Age ≥ 18
5. Native mitral valve geometry and size compatible with the Intrepid™ TMVR
6. No or minimal mitral valve calcification
7. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits

Exclusion: Please contact the research coordinator for the list of exclusions.

Principle Investigator: Paul Grayburn, MD, FACC

Who to contact for more information: Emily Laible, RN, BSW, CCRC
214-820-9903