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Topic 1:

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)
Research area:
Heart Failure
Principal investigator:
Cara East, MD
Type of study:
Interventional

Study synopsis:
This study evaluates the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (HF-MACE), preventing further adverse cardiac remodeling (LVESV and LVEDV), and increasing exercise capacity (6MWT) in patients with chronic heart failure due to left ventricle systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

“Medicines are the backbone of treatment for a failing heart, but there are times that medicines stop working. If the heart becomes severely ill, the treatment options are heart transplant or mechanical heart implant. Stem cells provide an option when the medicines are not working and the advanced therapies are not an option. We have been implanting stem cells as part of research studies for eight years and think this can be the future of heart failure care.” Cara East, MD, principal investigator

Study objective:
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in he treatment of chronic heart failure due to LV systolic dysfunction.

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT02032004?term=rexlemestrocel-L&cond=Heart+Failure&rank=1

Study contact:
Merielle Boatman, MBA, BAAs, Merielle.Boatman@bswhealth.org, 214-820-2273




Topic 2:

Transcatheter Mitral Valve Replacement With Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)
Research Area:
Mitral Valve Regurgitation
Principal investigator:
Ravi Vallabhan, MD, FACC
Type of study:
Interventional -- multi-center, global, prospective, randomized, interventional pre-market trial

Study synopsis:
This study evaluates whether TMVR is non-inferior to conventional mitral valve surgery at one year for patients with severe symptomatic native mitral regurgitation. Study subjects are 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.

“I have had a significant interest in valvular heart disease since starting my practice in 1996. For me, Transcatheter Aortic Valve Replacement (TAVR) has been a truly revolutionary technology for the treatment of aortic valve stenosis since 2011 in the US. The impact on the treatment of AV stenosis has been far greater than most cardiologists and the medical community in general ever expected in such a short period of time. This has resulted in significant interest in percutaneous options for the treatment of mitral valve (MV) disease (both stenosis and regurgitation), which is the next major frontier in the treatment of valvular heart disease. We are one of a few select centers in the country chosen to participate in the APOLLO trial. This trial uses an intervention for patients with severe mitral regurgitation and is a truly revolutionary design for this type of valve. This trial is important as many previous percutaneous MV therapies have failed and the search for a consistently viable option is continuing. If successful, it will greatly increase the scope of patients for which we can offer transcatheter therapies for severe mitral regurgitation. This trial is important in helping establish Baylor Heart and Vascular Hospital - Dallas and Baylor University Medical Center as a leading center for the treatment of all types of valvular heart disease, both from a surgical and percutaneous approach.” Ravi Vallabhan, MD, principal investigator

Study objective:
The study will compare participants with mitral valve regurgitation who are treated with the Medtronic Transcatheter Mitral Valve Replacement System to those who a treated with conventional Surgical Mitral Valve Replacement. Primary outcomes measures include all-cause mortality, all stroke, reoperation or reintervention, and cardiovascular hospitalization.

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT03242642?term=Medtronic+Intrepid+TMVR&cond=Mitral+Regurgitation&cntry=US&state=US%3ATX&city=Dallas&rank=1

Study contact:
Emily Laible, RN, BSW, CCRC, Emily.Laible@BSWHealth.org, 214.820.9903




Topic 3:

Trial of MK01242 (Vericiguat) in Subjects with Heart Failure with Reduced Ejection Fraction (HFrEF) (VICTORIA)
Research area:
Heart Failure
Principal Investigator:
Peter McCullough, MD, MPH

Study synopsis:
This study compares the safety and efficacy of the drug MK-1242 (Vericiguat) compared with placebo added to the best usual treatment of patients diagnosed with heart failure with reduced ejection fraction (HFrEF).

“Baylor Scott and White Heart and Vascular Institute is pleased to offer this study to our patients who have been recently hospitalized due to heart failure. This is in an exciting new class of medications that has favorable effects on the heart, blood vessels, and kidneys in preclinical studies. Because it is given in addition to usual medications for heart failure, particular attention is paid to blood pressure and laboratory changes. In my view, we have had tremendous success with heart failure and medications such as this hold the promise of providing improvements in symptoms and reducing the risk of hospitalization and other complications.”
Dr. Peter McCullough, MD, principal investigator

Study objective:
The effectiveness and safety of Vericuguat in heart failure patients with reduced ejection fraction will be studied using two groups – one group that receives Vericuguat and a control group that will receive a placebo. The hypothesis of the study is that using Vericuguat with this patient population will increase the time to first occurrence of the composite of cardiovascular death or heart failure hospitalization in study participants with reduced ejection fraction.

Main/critical inclusion and criteria:
A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/study/NCT02861534?term=vericiguat&cond=Heart+Failure&rank=1#locn

Study contact:
Laura Clariday, Laura.Clariday@BSWHealth.org or call 214-820-7224.




Topic 4:

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.

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