Congestive Heart Failure Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following congestive heart failure clinical trials:
Lixivaptan in Patients with Heart Failure and Low Blood Sodium (BALANCE Trial)
Principal Investigator: Bojan Cercek, MD
IRB Approval Number: 13833
Contact: David Gallegos, RN (310) 423-4993
Recruiting
Summary: This is a Phase III, randomized , double-blind, placebo controlled, parallel study of oral lixivaptan in the management of hyponatremia (low blood sodium) in subjects with heart failure whose bodies are retaining too much water. Subjects will be enrolled while hospitalized and receiving the standard medications for heart failure. This study will determine whether administration of lixivaptan can effectively and safely produce an increase in serum sodium from baseline ( blood sodium levels > 120 to <130 mEq/ Liter). Lixivaptan is a potent, nonpetide selective antagonist for the vasopressin V2 receptor expressed primarily in the kidney resulting in the physiologic effect of free water excretion, thus decreasing urine osmilality, increasing urine flow and increasing serum osmolality.
HOMEOSTASIS: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients
Principal Investigator: P.K. Shah, MD
IRB Approval Number: 6773
Contact: Mitch Gheorghiu (310) 423-6152
Recruiting
Summary: The objective of this study is to find out how well the HeartPod System (an investigational implantable device) can detect changes in the pressure inside the upper left chamber of the heart. Based on the pressure readings, heart failure therapy can be fine-tuned. This may help prevent heart failure symptoms from occurring and reduce the number of hospital admissions. The HeartPod System consists of a sensor implanted by minimally invasive cardiac catheterization procedure (similar to pacemaker insertion) into the left atrial heart wall. The implant¿s readings are communicated through a hand-held computer called Patient advisory Module or PAM. The primary end point is safety of the device implantation assessed as freedom from Major Adverse Cardiac and Neurological Events at 6 weeks. The secondary end points are reliability and functionality of the device. To be included in the study, patients should have been diagnosed with heart failure for more than 6 months and had at least one hospitalization for heart failure in the past year.
Depression and Psychosocial Factors in Patients with Chronic Heart Failure
Principal Investigator: Ernst Schwartz, MD
IRB Approval Number: 13766
Contact: (310) 423-3851
Recruiting
Summary: The purpose of this research study is to explore how depression may affect heart failure (HF) patients' health. The study will be carried out at the Heart Failure and Transplant Clinic of the Cedars-Sinai Medical Center. Information obtained from 150 participants will be used to investigate the following three questions. First, we will try to determine how common depression is among patients diagnosed with HF. Second, we will examine whether depression makes HF patient's recovery more difficult. Third, we will explore how depression may affect recovery of HF patients.
Reduce HF- Reducing Decompensation Events Utilizing Intra-Cardiac Pressures in Patients with Chronic Heart Failure with the Chronicle Implantable Cardioverter Defibrillator
Principal Investigator: Lawrence Czer, MD
IRB Approval Number: 14877
Contact: David Gallegos, RN (310) 423-4993
Recruiting
Summary: REDUCE ¿HF is a trial designed to assess the safety and effectiveness of the Chronicle Implantable Cardioverter Defibrillator (ICD) system. This single chamber ICD with a heart pressure monitoring system will be used in the medical management of subjects with moderate chronic heart failure. The subjects enrolled will have clinical indications for ICD implants.
All subjects will be implanted with a Chronicle ICD and will be randomized to the Chronicle group or Control group. All patients will receive optimal medical therapy, but the heart pressure information from the device will be used to guide patient management only in the Chronicle group for the first 12 months of the study. During this first year, the research team will not have access to the heart pressure information from the implants in the control group.
