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Clinical Trials

Clinical Trials

Overview

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:
Puja Garg, PhD, CCRP (Office 214-820-7391)
Rebecca Baker, RN (Office 214-820-7965)

Overview

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:
Puja Garg, PhD, CCRP (Office 214-820-7391)
Rebecca Baker, RN (Office 214-820-7965)

Overview

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: Brian Lima, MD

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

Overview

Baylor Hypertrophic Cardiomyopathy Program Development Project

Time-resolved, 3D Phase Contrast Magnetic Resonance Imaging (MRI) (4D Flow) and Advanced Strain Rate Echocardiography in Patients with Hypertrophic Cardiomyopathy

The purpose of the this research study is to evaluate 4D flow characteristics that may lead to new insights on the detection of HCM by clinical exam, echocardiography with strain rate, and MRI examinations.

Inclusion

  • Age ≥18 for subjects whose HCM was diagnosed by conventional echocardiogram and/or confirmed by previously performed genetic testing. (1022)

Exclusion

  • Allergy to gadolinium or gadodiamide
  • Severe claustrophobia or unable to undergo MRI

Principle Investigator: Peter McCullough, MD

For more information regarding enrollment of this trial, please contact Love Ko at Jong.Ko@bswhealth.org.

Overview

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 Katherine Panettier-Kennedy at Katherine.PanettiereKennedy@BSWHealth.org.


Prior Clinical Trials Information

SPIRE 1 and 2

The purpose of this research study was to compare the effects of the study drug, bococizumab (also called PF-04950615), with a placebo to find out how effective and safe bococizumab is in preventing major cardiovascular events, (heart attacks, strokes, and hospitalization for chest pain), when added to other cholesterol treatments.

Primary Investigator
Peter McCullough, MD

Symplicity

Baylor researchers are studying a new approach that could help normalize blood pressure-without medication. The Symplicity trial is testing a minimally invasive procedure known as renal denervation. The experimental procedure uses heat that is generated by radio frequency to disrupt nerve communication to and from the kidneys. This can reduce over activity in the sympathetic nervous system, a frequent cause of chronic high blood pressure.

CoreValve Transcatheter Valve

The Baylor team has now implanted 14 of these valves (16 randomized), which are implanted transcutaneously, for severe or critical aortic stenosis. This provides an option for treatment of patients who could not undergo open-heart surgery.

Primary Investigators
Robert Stoler, MD
Robert F. Hebeler, MD
Paul Grayburn, MD

VIRGO

The Baylor sites enrolled over 70 patients in this observational registry of women and men (enrolled 2:1) under the age of 55 who have had proven myocardial infarctions. Study includes demographics, psychosocial factors, biomarkers, and gene testing.

Primary Investigators
Deepika Gopal, MD
Cara East, MD


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