Outcomes 2019 - Baylor Scott & White Heart and Vascular Hospital BSWHHVH_646_2019 Outcomes JOOMAG MOD | Page 71

Principal investigator for this trial is Peter
McCullough, MD, medical director, Cardiovascular
Research and Education – Dallas campus – Baylor
Scott & White Heart and Vascular Institute,
and program director, Cardiology Fellowship
Program – Baylor University Medical Center.
Heart failure research studies – top studies
for FY19
Randomized Placebo-Controlled Trial of FCM as
Treatment for Heart Failure with Iron Deficiency
(HEART-FID) is designed to determine the efficacy
and safety of iron therapy using intravenous ferric
carboxymaltose (FCM), relative to placebo, in the
treatment of participants in heart failure with iron
deficiency and with a reduced ejection fraction.
The principal investigator is Shelly Hall, MD, chief,
Transplant Cardiology, Mechanical Circulatory
Support and Heart Failure – Baylor University
Medical Center.
Clinical Study to Assess the Efficacy and Safety
of Macitentan in Patients with Pulmonary
Hypertension After Left Ventricular Assist Device
Implantation (SOPRANO) evaluates:
• The effectiveness of macitentan 10 mg
on pulmonary vascular resistance (PVR)
• The effect of macitentan 10 mg as
compared to placebo on cardiopulmonary
hemodynamics and disease severity in
subjects with PH after LVAD implantation
• 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.
The principal investigator is Shelley Hall, MD.
Fort Worth campus research FY19
AMPLATZER™ Amulet™ LAA Occluder Trial
(AMULET IDE) is designed to evaluate the safety
and effectiveness of the AMPLATZER Amulet Left
Atrial Appendage Occluder. Study participants are
randomized in a 1:1 ratio between the Amulet LAA
occlusion device (treatment) or the WATCHMAN ®
LAA closure device (control). Principal investigator
is Craig Delaughter, MD, medical director of
Electrophysiology, Baylor Scott & White Heart
and Vascular Hospital – Fort Worth.
as compared to placebo in subjects with
pulmonary hypertension (PH) after left
ventricular assist device implantation
Additional Fort Worth campus studies are:
• PRECISION GRX Registry: a multicenter
post-market registry for the evaluation of
the CorPath ® GRX System effectiveness in
percutaneous coronary interventions. The
principal investigator is Srinivasa Potluri, MD,
and sub-investigator is Farhan Ali, MD.
• MORE: An Abbott study of the impact of
Multi-Point Pacing in the treatment of
patients not responding to standard Cardiac
Resynchronization Therapy (CRT). The
principal investigator is Syed Shah, MD, and
sub-investigator is Craig Delaughter, MD.
• WaveCrest: A study to evaluate the safety
and effectiveness of the WaveCrest device in
subjects who have atrial fibrillation by comparing
it to a similar devices called Watchman ® Left
Atrial Appendage Closure device. The principal
investigator is Craig Delaughter, MD, and sub-
investigator is Farhan Ali, MD.
EXTEND CRS is Baylor Scott & White’s largest
investigator-initiated grant funding an original
randomized trial in which patients are testing an
established medication, exenatide for diabetes,
and undergoing extensive cardiac testing,
including advanced magnetic resonance imaging
and strain rate echocardiography. Patients enrolled
in the study have cardiac MRI images taken when
they begin the trial and again after treatment with
exenatide, an injectable drug for Type-2 diabetes.
The data obtained from the images is compared
with strain rate echocardiography and novel
proteomic biomarkers in an effort to develop
innovative measures of disease progression
and improvement. The goal of this study is to
understand how diabetes medications affect the
heart in terms of its morphology and its protein
expression. Cardiac MRI is also being used in the
Baylor Hypertrophic Cardiomyopathy Program to
assess cardiac morphology in this inherited form
of heart disease and is better informing physicians
on the need for life-saving treatments.
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