Nationally Recognized Heart Hospital
Dallas   Fort Worth



Find a Physician

Advanced Search


Soltero Cardiovascular Research Center
Clinical Trials

Coronary Artery Disease

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:
Sharla Russell Sharla.Russell@BSWHealth.org

Lp(a) in CVD Patients

Lipoprotein(a) in Patients With Cardiovascular Disease
This is a multi-center cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp(a) in patients with established CVD defined by their medical history. One study visit is planned for data collection. Relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period will be collected retrospectively. In the event that laboratory data are not available, blood sampling will be performed.

Study Objective: The study will be conducted using one study visit and analyzing participants’ relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period. In case laboratory data are not available, blood sampling will be performed.

“Individuals with established cardiovascular disease (CVD) often have elevated levels of lipoprotein(a),” said Cara East, MD, FAPCR, FACP, FACC, Director of Soltero Cardiovascular Research Center, a cardiologist on the medical staff of Baylor Scott & White Health, and the study’s principal investigator. “The study is looking at levels of Lp(a) which is a novel cholesterol particle which causes hardening of the arteries. This study aims to see how many patients with heart disease have high Lp(a) levels.”

Main inclusion/exclusion criteria: A complete list of inclusion and exclusion criteria may be found at https://clinicaltrials.gov/ct2/show/NCT03887520?term=CTQJ230A12001&draw=2&rank=1

Principal investigator: Cara East, MD, FAPCR, FACP, FACC For more information regarding enrollment in this trial, please contact Shanet Stefanos, Shanet.Stefanos@BSWHealth.org, or call Soltero Cardiovascular Research at 214.820.2273.

Heart Failure

ARRAY

Primary objective: Evaluate the effect of ARRY-371797 on functional capacity (as measured by the 6-minute walk test [6MWT]) compared to placebo in NYHA Class II-IV patients.

This is a randomized, double-blind, placebo-controlled study in NYHA class II-IV patients with dilated cardiomyopathy (DCM) due to a gene encoding the lamin A/C protein (LMNA) mutation. The study will further evaluate a dose level of ARRY-371797 that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may receive open-label treatment with ARRY-371797.

Inclusion criteria:

  • Known or suspected Lamin A/C mutation related to DCM- Dilated Cardiomyopathy
  • NYHA Class 2 – 4
  • Gene positive for a deleterious mutation in LMNA gene
  • ICD ( greater than 4 weeks prior to study treatment) or CRT-D (greater than 6 weeks prior to study treatment)
  • There is criteria that will prompt generic screening. Please contact the research coordinator for more information.


Exclusion criteria:
  • Presence of other form(s) of cardiomyopathy contributing to HF (e.g., inflammatory or infiltrative cardiomyopathy) or clinically significant cardiac anatomic abnormality (e.g., LV aneurysm);
  • Clinically significant coronary artery disease (e.g., coronary revascularization, exercise-induced angina) per Investigator judgment; Uncorrected, hemodynamically significant (i.e., moderate-severe) primary structural valvular disease not due to HF
  • Currently receiving or deemed at high risk of requiring chronic renal replacement therapy (e.g., hemodialysis or peritoneal dialysis) within 6 months
  • Treatment with any investigational agent(s) for HF within 28 days prior to Day 1. Any treatment with an investigational agent(s) requires approval from the Medical Monitor
  • Malignancy that is active or has been diagnosed within 3 years prior to screening, except surgically curatively resected in situ malignancies or surgically cured early breast cancer, prostate cancer, skin cancer (basal cell carcinoma, squamous cell carcinoma) or cervical cancer
  • Non-cardiac condition that limits lifespan to < 1 year; Serum positive for hepatitis B surface antigen, viremic hepatitis C, or human immunodeficiency virus (HIV) at screening.
  • Please contact the research coordinator for more information.
For further information regarding this study, please contact Baylor Scott & White Heart and Lung Transplant & Pulmonary Department at 214-820-0338 or via email at HLTPRESEARCHDEPARTMENT@BSWHealth.org

Principle Investigator: Robert Gottlieb, MD
Research Coordinator: DONNA.CLARK1@BSWHEALTH.ORG

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

Learn more about the study

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



Learn more about the study

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



Learn more about the study

GALACTIC-HF

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:

  • Age/Sex = 18 to 85, female or male
  • History of chronic HF
  • LVEF 35 percent or less, within 12 months prior to screening
  • NYHA class II to IV at most recent screening assessment
  • Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject’s clinical status
  • Current hospitalization with primary reason of HF, OR one of the following events within one year of screening: hospitalization with primary reason of HF; urgent visit to emergency department with primary reason of HF
  • Elevated BNP or NT-proBNP
Exclusion:
  • Currently receiving treatment in another investigational device or drug study, OR less than 30 days since ending treatment on another investigational device or drug study
  • Malignancy within five years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage one prostate carcinoma, breast ductal carcinoma in situ
  • Known sensitivity to any of the products or components to be administered during testing
Principal investigator: Susan Joseph, MD
For more information regarding enrollment in this trial, please contact Taylor Poyner, at Taylor.Poyner@BSWHealthorg.



Learn more about the study

GUIDE-HF

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 Failure Hospitalization within 12 months
  • LVEF ≤ 40%: BNP ≥ 250 pg/mL
  • LVEF > 40%: BNP ≥ 175 pg/mL
Exclusion Criteria
  • GFR < 25 mL/min/1.73m2
  • Severe Pulmonary Hypertension
  • Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent.


Primary Investigator: Shelley Hall, MD, FACC, FHFSA

Horacio Martinez, BS, CCRC, Horacio.Martinez@BSWHealth.org, 214.820.0338.



Learn more about the study

HEART-FID

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.



Learn more about the study

INVESTED

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:

  • Age = 18
  • History of hospitalization for myocardial infarction within one year of enrollment OR a history of hospitalization for heart failure within two years of enrollment
  • At least one of the following risk factors:
    • Prior MI (if HF the index event above; or a second MI)
    • Prior HF hospitalization (if MI the index event above; or a second HF event)
    • Age = 65 or older
    • LVEF < 40 percent
    • Diabetes mellitus
    • Obesity (BMI = 30 or more)
    • Renal impairment (eGFR = 60 or less)
    • History of ischemic stroke
    • History of peripheral artery disease
    • Current smoker
Exclusion:
  • Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barre Syndrome within six weeks after influenza vaccine
  • Ay non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than nine months
  • Receipt of influenza vaccine during current influenza season
  • Any illness requiring treatment with antibiotics or anti-inflammatory medication within the past 14 days.

Principal investigator:
Peter McCullough, MD, MPH, FACC, FACP, FAHA, FCCP, FNKF, FNLA, FCRSA
For more information regarding enrollment in this trial, please contact Laura Clariday, at Laura.Clariday@BSWHealth.org.



Learn more about the study

MOMENTUM 3 CAP 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 Horacio Martinez at Horacio.Martinez@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

Reduce LAP-HF

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:

  • Are you over 40 years of age?
  • Are you taking diuretics?
  • Have you been hospitalized for heart failure within the past year?
  • Has your doctor diagnosed you with heart failure or HFpEF?
  • Has your doctor told you your heart is weak or not contracting strongly enough?
  • Is your echocardiographic LV ejection fraction 40% or higher?
Exclusion Criteria:
  • Are you allergic to nickel?
  • Is your hemoglobin less than 10g/dl?
  • Is your systolic blood pressure higher than 170mmHg?
  • Is your resting oxygen saturation less than 95%
Primary Investigator: Susan Joseph, MD

Contact for more information: Horacio.Martinez@BSWHealth.org



Learn more about the study

SOPRANO

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.

SPIRRIT

SPIRRIT: Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT)

The study will evaluate heart failure patients with preserved ejection fraction (HFPEF) in the Swedish Heart Failure Registry (2550 patients) and HFPEF patients in US (650 patients). HFPEF is defined as symptoms/signs of heart failure (HF), elevated NTproBNP (B-type Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF>=40%. Intervention and control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual care alone.

Study Objectives: This study has one primary and several secondary outcome objectives. Primary outcome is cardiovascular death or time to HF hospitalization. Secondary outcomes include hospitalization for various causes, adverse events and treatment adherence. In Sweden outcomes are obtained automatically by linking with the Population, Patient and Drug Dispensed Registries. In the US, outcomes will be reported by sites and supplemented by data from a call center. The trial is event-driven with enrollment 3 years and study duration 5 years. For the primary outcome (CV Death or first HF hospitalization) with an event target of 632 events the sample size requires 3012 patients conservatively rounded to approximately 3200 patients. A detailed feasibility assessment shows that there will be > 8197 eligible patients to meet the required enrollment of 3200 patients.

“The SPIRRIT trial is focused specifically on patients with heart failure and a preserved ejection fraction,” said Timothy Gong, MD, a cardiologist specializing in advanced heart failure on the medical staff of Baylor Scott & White Heart and Vascular Hospital – Dallas and principal investigator for SPIRRIT. “I am interested in this trial because there are no therapies for these patients with a proven mortality benefit. I hope that a trial of this magnitude will shed light on future therapies for this disease.”

Main inclusion/exclusion criteria: A complete list of inclusion and exclusion criteria may be found at https://www.clinicaltrials.gov/ct2/show/NCT02901184?term=SPIRRIT&draw=2&rank=1

Principal investigator: Timothy Gong, MD
For more information regarding enrollment in this trial, please contact Shane.Blankenship@BSWHealth.org

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:
Laura Clariday Laura.Clariday@BSWHealth.org

Learn more about the study

Hypertension

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

Prevention

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



 Find A Physician


 Download the App


 Let's Chat


 HeartSpeak Podcast



Warning

Your Session will expire in 5 minutes

Please click the "Continue Session" button below to continue using the website. To end your session please click the "End Session" button below. After 5 minutes of inactivity your session will be terminated and you will be required to log in again.