Congestive Heart Failure Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following congestive heart failure clinical trials:
• Advanced Heart Failure Treatment Effects on Outcomes
• Depression and Psychosocial Factors in Patients with Chronic Heart Failure
• Evaluating weight loss after ventricular assist device implantation
• HOMEOSTASIS: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients
• Reduce HF- Reducing Decompensation Events Utilizing Intra-Cardiac Pressures in Patients with Chronic Heart Failure with the Chronicle Implantable Cardioverter Defibrillator
• The Economic Impact on Heart Failure
• The Evaluation of Quality of Life in Heart Transplant, Left-Ventricular Assist Devices (LVADs), and Advanced Heart Failure Patients
• TOPCAT: Treatment Of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist
Advanced Heart Failure Treatment Effects on Outcomes
Principal Investigator: Ernst Schwarz, MD
IRB Approval Number: 20536
Contact: Sandra Zaldivar (310) 423-1876
Status: Enrolling
Summary: The purpose of the current research is to perform a retrospective study, looking at patients with advanced heart failure, NYHA Class III and IV, to evaluate the relationship between the therapeutic strategies used in the management of these patients and their morbidity, mortality and clinical outcomes. This will aid in determining the benefits of newer treatment strategies, such as inotropes and implantable defibrillators, in patients with advanced heart failure.
Depression and Psychosocial Factors in Patients with Chronic Heart Failure
Principal Investigator: Ernst Schwarz, MD
IRB Approval Number: 13766
Contact: Sandra Zaldivar (310) 423-1876
Status: Enrolling
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.
Evaluating weight loss after ventricular assist device implantation
Principal Investigator: Ernst Schwarz, MD
IRB Approval Number: 18574
Contact: Sandra Zaldivar (310) 423-1876
Status: Enrolling
Summary: Left ventricular assist devices have been implemented in heart failure patients for quite some time, providing a bridge to transplant for individuals deemed appropriate candidates. Unfortunately, several restrictions limit the implementation of ventricular assist devices. One of the key limiting factors is the weight of the patient. Many heart failure patients are obese or super obese and are often unable to received assist devices due to poorer outcomes as a result of this relative contraindication. The department of cardiology at Cedars Sinai implements the use of ventricular assist devices on a regular basis and a trend has been appreciated in which patients that receive the devices seemingly lose weight and decrease their BMI as a result of having the ventricular assist devices implanted. This study hopes to evaluate the potential effect on weight in obese patients with ventricular assist devices.
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
Status: Enrolling
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.
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: (310) 423-3851
Status: Follow-up
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.
The Economic Impact on Heart Failure
Principal Investigator: Ernst Schwarz, MD
IRB Approval Number: 19639
Contact: Sandra Zaldivar (310) 423-1876
Status: Enrolling
Summary: The purpose of this study is to determine the financial impact of the current financial recession in the United States on hospitalization rates for heart failure. While economics undoubtedly plays a role in many diseases, we chose heart failure a model system for several reasons. First, heart failure is one of the most common causes for hospital admission, which will allow large enough sample size to achieve statistical significance in our analysis. Additionally, unlike other illness, admission to the hospital for symptomatic heart failure can usually be directly linked to a patient’s noncompliance with their home medications; often this is clearly documented in the patient’s medical record. Lastly, the reason for noncompliance is often because patients are unable to afford their medications. Given this, we believe that studying heart failure admissions to Cedars-Sinai Medical Center will provide an ideal model for studying the economic effects on hospitalization rates. We hypothesize that since the beginning of the economic recession there has been an increase in the number of hospital admissions for heart failure when compared to a time of economic proliferation 2 years prior. We also hypothesize that this increase in admissions can be directly tied to the current financial status of the United States.
The Evaluation of Quality of Life in Heart Transplant, Left-Ventricular Assist Devices (LVADs), and Advanced Heart Failure Patients
Principal Investigator: Ernst Schwarz, MD
IRB Approval Number: 19029
Contact: Sandra Zaldivar (310) 423-1876
Status: Enrolling
Summary: The purpose of this study is to evaluate qualify of life issues in patients with advanced heart failure. We will study and evaluate heart failure patients with NYHA stage III and IV heart failure, patient’s prior to the placement of LVAD (left ventricular assist devices which helps the heart pump blood), patients with LVAD already placed, and patients prior to heart transplant surgery. These patients will be given a set of standardized questionnaires to be answered during their initial session, then within two months of the original session, three months, one year, and at two years. The questionnaires are designed to assess mood, well being, and sexual functioning. The identical set of questionnaires will be re-administered a total of five times. Recruitment of patients will take place by referral from the
advanced heart failure clinic or as an inpatient when a patient is listed for a LVAD or a heart transplant. Patients will be recruited to participate in the study by a Principal or co-Investigator.
TOPCAT: Treatment Of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist
Principal Investigator: Robert Davidson, MD
IRB Approval Number: 13794
Contact: Robert Davidson, MD (310) 423-6737 or (310) 855-1971
CAPRI (310) 657-1913 (ask for Ronnie)
Email: Capri-tcr@netscapte.net
Status: Enrolling
Summary: This is a multicenter, international, randomized double blind placebo-controlled trial of 4500 adult patients with heart failure recruited from over 150 clinical centers. This trial is sponsored by the National Heart, Lung and Blood Institute of the National Institutes of Health. The purpose of this study is to determine if adding the drug spironolactone to the current treatments for heart failure improves heart failure in patients who are already on standard treatment for this condition. This study examines the safety and effectiveness of spironolactone compared with placebo in the treatment of adults with heart failure and a normal or slightly decreased level of heart contraction.
