Congestive Heart Failure Clinical Trials

Cedars-Sinai Heart Institute is currently conducting the following Congestive Heart Failure Clinical Research trials:

 

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study (LAPTOP-HF)

IRB Approval No.: 22843

Status: Enrolling

Contact: Maria Thottam, Study Coordinator, (310) 248-7132

Project Summary: The purpose of this clinical investigation is to evaluate the safety and clinical effectiveness of the Sponsor’s LAP Monitoring Systems linked with a physician-directed, patient self-management therapeutic strategy to limit LAP excursions in ambulatory patients with advanced heart failure (Treatment group) with a Control group receiving optimal medical therapy in a prospective randomized multicenter trial. The fundamental hypothesis is that long-term direct left atrial pressure monitoring combined with a system of physician-directed daily patient self-management will improve hemodynamics and limit hospitalization for ADHF in patients with advanced heart failure. Although direct LAP monitoring is more invasive and may have higher device-related risks than right-sided cardiac pressure monitoring, other approaches that measure right sided pressure have practical barriers to data acquisition and inherent limitations in predictive value that may limit basing therapy on daily measurements thus adversely affecting potential benefits. The LAPTOP-HF study protocol requires placing a pressure-sensing lead (known as the HeartPOD® Implantable Sensor Lead (ISL) into the left atrium by transseptal catheterization. The ISL may be implanted from either a superior venous access site (subclavian or axillary veins) or an inferior venous access site (femoral veins). The primary safety endpoint is freedom from Study-Related (procedure or device) Major Adverse Cardiovascular and Neurological Events (MACNE) relative to objective performance criteria. The secondary safety endpoint will compare All-Cause MACNE in the Treatment group and the Control group. Effectiveness will be determined by evaluating cumulative Heart Failure MACNE (synonymous with Heart Failure Hospitalization) in the Treatment group vs. the Control group until a specified number of events have been observed. The secondary effectiveness endpoints will compare days alive and out of the hospital for HF events and All-Cause Death in the Treatment and Control groups. The patient population being studied includes patients with ischemic or non-ischemic cardiomyopathy with a history of heart failure for at least 6 months.

 

Observational Review of Clinical Outcomes in Heart Failure Patients Undergoing Bariatric Surgery

IRB Approval No.: 29045

Status: Enrolling

Contact: Maria Thottam, Study Coordinator, (310) 248-7132

Project Summary: Obesity in those with advanced heart failure limits their treatment options, as guidelines supports that a BMI of < 30 kg/m2 is recommended prior to listing for cardiac transplantation. Weight reduction is therefore essential for survival in those with advanced heart failure, although due to the obesity paradox, it remains unclear if weight loss is harmful in this population. Further studies are therefore needed not only to clarify the impact of decreased weight in patients with advanced HF, but to provide the appropriate management of these patients in order avoid worsening outcomes and offer all therapeutic options available. This is an observational study to evaluate the safety and feasibility of bariatric surgery in high risk obese patients with heart failure and its impact on cardiac function and functional status. Twenty patients will be enrolled in this study and their participation is expected to last two years. After having bariatric surgery, heart failure cardiologists will observe patients' progress following the surgery.

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