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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)
  • HOMEOSTASIS: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients
  • Cardiac Resynchronization Therapy (CRT) Optimization by SphygmoCor
  • Tissue Doppler and Echocardiographic Criteria to Predict Better Outcome after Cardiac Resynchronization Therapy


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.

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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.

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Cardiac Resynchronization Therapy (CRT) Optimizaion by SphygmoCor

Principal Investigator: Tasneem Naqvi, MD

IRB Approval Number: 8850

Contact: Asim Rafique (310) 423-6860

Recruiting

Summary: About 20-30% of the patients do not respond well to cardiac resynchronization therapy. Optimization of various pacemaker parameters is one potential way of reducing non response rate to Cardiac Resynchronization Therapy (CRT) which works by improving synchrony between the atrial and ventricular chambers of the heart as well as synchrony between right and left ventricles via atrioventricular and ventriculoventricular optimization procedure. SphygmoCor, a simple, non-invasive, bed-side device has been used in a pilot study and found to be promising in helping pacemaker optimization. SphygmoCor detects peripheral arterial pulse by a tonometer that is placed over radial artery. The purpose of this study is to further refine the novel use of the SphygmoCor device in (CRT) optimization during both atrioventricular and ventriculoventricular programming.

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Tissue Doppler and Echocardiographic Criteria to Predict Better Outcome after Cardiac Resynchronization Therapy

Principal Investigator: Tasneem Z. Naqvi, MD

IRB Approval Number: 6276

Contact: Asim Rafique or Monica Acevedo (310) 423-4158

Recruiting

Summary: The objective of this study is to predict the improvement in left ventricular function after cardiac resynchronization therapy. Patients are routinely evaluated for the presence or absence of mechanical dyssynchrony as part of standard clinical care. The goal is to evaluate the role of dyssynchrony assessment by Tissue Doppler Echocardiography in larger number of patients and find the best possible criteria. To be included in the study, patients should have heart failure which is resistant to medical treatment and on optimal medical treatment for past 6 months, had no coronary event or procedure after biventricular pacemaker implantation and have evaluation of dyssynchrony before placement of Cardiac Resynchronization Therapy

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