The purpose of this research study is to test if ARRY-371797 is safe and effective in treating dilated cardiomyopathy caused by a genetic mutation to the LMNA gene. This will be demonstrated by the functional capacity of patients in their 6-minute walk tests and quality of life questionnaires.
The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM.
The purpose of this research study is to understand the association between heart and brain health in a population of 40-75 year olds. In this study, we will work to better understand blood vessel stiffness and brain function in African American and non-Hispanic white individuals. You will be asked to give blood during the study visit. Additional information will be obtained to help the researcher better understand the blood vessel and brain function data collected. There is only one study visit that last roughly 2 hours and compensation will be available.
The purpose of the study is to test a new way to pace the left side of the heart without using pacing leads, using the WiSE CRT System. In this study, ultrasound will be used to transfer energy from a new type of pacemaker through your body to a special receiver that is placed inside the left ventricle of your heart. The receiver will use the ultrasound energy to pace the heart without using pacing leads.
Peripheral vascular interventions are minimally invasive options for the treatment of patients with peripheral arterial disease (PAD). Unfortunately, the effects of this procedure are short-term and there remains a high rate (40-70%) of restenosis (re-narrowing of the arteries). The purpose of this research study is to determine if the use of the catheter for the delivery of the study drug called paclitaxel, will prevent re-narrowing of the blockage of an artery to be treated in the leg.
This is an ancillary study on the Phase 3 parent trial (CREST-2) in which patients with asymptomatic high grade carotid artery stenosis have enrolled to receive either a novel intensive medical management plan alone, or in combination with either Carotid Endarterectomy (CEA) or Carotid artery stenting (CAS). Patients enrolled in CREST-H will undergo a baseline MRI and some patients will also undergo a followup MRI at 1 year. The purpose is to determine whether cognition can be improved by revascularization among the subset of CREST-2 patients with hemodynamic impairment and mild cognitive impairment at baseline.
Pre-eclampsia (PE) happens in pregnancy. It features new onset high blood pressure. It is a major cause of problems to the mother and unborn child. It can lead to health problems in mother and child in the future, which causes a public health problem. We do not know everything about it, but we think it starts in the placenta (the organ that nourishes the unborn child). At this time, we do not know who will get PE. We want to study the placenta, to learn more about the disease.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban (Eliquis) versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. 1100 subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.
?Male or female patient, age >= 18 years at screening.
?Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
?Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
?Stable dose of oral diuretics, if prescribed
?Signed and dated written ICF (informed consent form)
?Further inclusion criteria apply
?Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
?Heart transplant recipient or listed for heart transplant
?Acute decompensated HF (Heart Failure)
?Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
?Symptomatic hypotension and/or a SBP < 100 mmHg
?Indication of liver disease,
?Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
?History of ketoacidosis
?Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
?Currently enrolled in another investigational device or drug trial
?Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
?Women who are pregnant, nursing, or who plan to become pregnant while in the trial
?Further exclusion criteria may apply
The purpose of the study is to see if a new investigational drug called bempedoic acid reduces the risk of major cardiovascular (heart and blood vessel-related) events in patients with, or at high risk for, heart disease who have had complications related to taking statins. The study will compare bempedoic acid with a placebo to see if taking bempedoic acid is better than taking a placebo.