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Researchers in Northwestern Memorial Hospital's Center for Heart Failure at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating heart failure. The following clinical research trial(s), specific to heart failure, are currently recruiting volunteers. Clinical research trials search for new and better ways to understand and treat disease. Participating in a clinical research trial is an informative learning experience for the volunteer. Please consider volunteering in a clinical research trial as your participation will contribute to important advancements of medical knowledge. |
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| Name of Research Trial: | CTOT-05: Observational Study of Alloimmunity in Cardiac Transplant Recipients |
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| Principal Investigator: | William Cotts, MD |
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| IRB Project Number: | STU00000896 |
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| Description of Research Trial: | Individuals are being asked to participate in this research study that are about to receive a heart transplant. Following transplant, patients need to take a combination of drugs to prevent rejection of their new heart. Sometimes, even with medicine, the body has trouble accepting the new heart. The purpose of this study is to determine whether tests performed on blood, urine, and heart biopsy tissue, as well as tests looking at the blood vessels of one's heart, can predict rejection. If successful, this approach will allow physicians to tailor the treatment to individual patients with the goal of providing the most benefit with the least harm. Participation in the study will begin within 24 hours prior to the heart transplant. Participants will be in the study for 12 months after transplant. There will be a total of 6 study visits. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Katy Prendegast at (312) 695-3264 or e-mail kprender@nmh.org |
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| Name of Research Trial: | A Phase 1/2 Trial of Intracoronary Adminstration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure Divided into Two Stages: Stage One Open-Label, Sequential Dose-Escalation Cohorts and Stage Two Randomized, Double-Blind, Placebo-Control, Parallel Cohorts, also known as the "CUPID" Trial (Calcium Up-Regulation by Percutaneous Adminstration of Gene therapy In Cardiac Disease). |
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| Principal Investigator: | Douglas Losordo, MD |
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| IRB Project Number: | STU00005786 |
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| Description of Research Trial: | This study is being done to learn more about gene transfer in heart failure. It is meant to investigate the safety, possible harms, and side effects of infusing an experiemental gene transfer agent called MYDICAR® (the study drug) into the heart. The study involves the use of a virus to transport a gene into your heart to try to stimulate the production of an enzyme that is reduced in patients with moderate to severe heart failure. The study drug is infused through a small tube into the arteries of the heart during a procedure called a cardiac catheterization. The study will be conducted at approximately 15 medical centers in the United States and we hope to enroll at least 10 patients at Northwestern University. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Trocchio, RN at (312) 695-0045 or e-mail wtrocchi@nmh.org |
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| Name of Research Trial: | C-Pulse™ Implantable Counterpulsation Pump (ICP) |
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| Principal Investigator: | Edwin McGee, Jr., MD |
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| IRB Project Number: | STU00001522 |
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| Description of Research Trial: | This research study is looking for patients who have heart failure who have become resistant to medications. Currently, heart transplantation is the only widely accepted treatment option for patients with heart failure resistant to standard medications. Mechanical heart assist devices, pumps that do all the work of the heart to pump blood around the body, are used in some patients as a bridge-to-transplant, and in other patients who are not suitable for heart transplant, as a long-term implant (otherwise known as "destination therapy"). Such blood-contacting heart pumps require extensive surgery to implant, and cannot be turned off without the risk of permanent injury to the patient or death. The purpose of this research study is to evaluate a new heart assistance device, known as C-Pulse™. The C-Pulse™ device works to assist the heart to pump blood, rather than "replacing" the heart function; it does NOT contact the blood, and can be safely turned on or off as required. The C-Pulse™ is an experimental device, which means it is not yet approved by the Federal Food and Drug Administration (FDA) in the United States. Patients who are eligible to participate will have the study device surgically implanted. The C-Pulse™ Cuff is positioned around the aorta (the main artery coming out of the heart that delivers blood to the body). The Cuff deflates just before the heart pumps blood, reducing the workload of the heart, and the Cuff is timed to re-inflate in between heart beats, to help assist the heart in pumping blood. Reducing the load on the heart and increasing blood flow to the heart muscle are very important in assisting the heart's ability to pump blood around the body. There will be up to 20 patients enrolled in this study in the United States and up to 6 centers. Participation in the study and follow-up visits are expected to last up to 5 years. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Karissa Fortney, MSN, BS, RN at (312) 926-4801or e-mail k-fortney@northwestern.edu |
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| Name of Research Trial: | Evaluation of the HeartWare Left Ventricular Assist Device System for the Treatment of Advanced Heart Failure |
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| Principal Investigator: | Edwin McGee, Jr., MD |
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| IRB Project Number: | STU00005498 |
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| Description of Research Trial: | This research study is looking for patients who have end-stage heart failure and are on the heart transplant list. Heart failure occurs when the heart has become weak and cannot pump blood to the rest of the body as well as it should. In a healthy heart, the left ventricle pumps blood through the body. In a heart weakened by heart failure, the left ventricle is often not strong enough to pump the blood sufficiently. The purpose of this research study is to evaluate a new heart assist device, known as HeartWare Left Ventricular Assist Device (LVAD), as a treatment for end stage heart failure in patients who require circulatory assistance while waiting for a heart transplant. The HeartWare LVAD is a mechanical blood pump that provides your body with blood flow which is necessary to live. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Byron Yip at (312) 695-3270 or e-mail b-yip@northwestern.edu |
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| Name of Research Trial: | A Global, Multi-Center, Longitudinal, Observational Survey of Patients with Documented Transthyretin (TTR) Mutations or Wild-Type TTR Amyloidosis |
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| Principal Investigator: | Sanjiv Shah, MD |
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| IRB Project Number: | STU00004191 |
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| Description of Research Trial: | This study is being done to collect information on patients who have transthyretin-associated amyloidosis. This includes patients whose disease is hereditary (passed down from a parent to a child) and patients who have developed the disease spontaneously (not passed down by parent to child). Patients involved in the study will have medical information collected from visits to Northwestern University. As there are many unanswered questions about this disease, the Transthyretin-Associated Amyloidosis Outcome Survey (THAOS) was created in order to understand the disease better and improve the care of patients. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Katie Small at (312) 926-2773 or e-mail k-small@northwestern.edu |
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| Name of Research Trial: | TOPCAT - Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist |
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| Principal Investigator: | Sanjiv Shah, MD |
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| IRB Project Number: | STU00002714 |
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| Description of Research Trial: | The purpose of this study is to see if adding a drug called spironolactone to treatments for heart failure is able to safely improve one's heart failure condition. To be eligible for the study you must have both a history of heart failure and a certain level of heart contraction measured within the last 6 months (> 45% ejection fraction). The level of heart contraction, called left ventricular ejection fraction, is typically measured by an echocardiogram. 4500 adults ages 50 years or older from over 150 clinical centers around the world are being recruited for this study. At Northwestern University we hope to enroll 20-30 patients and Sanjiv Shah, MD is the principal investigator who will be overseeing the study at this site. Participation in this study may last up to four and a half years. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Katie Small at (312) 926-2773 or e-mail k-small@northwestern.edu |
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| Name of Research Trial: | Invasive Monitoring Attenuation through Gene Expression (IMAGE) Study |
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| Principal Investigator: | William Cotts, MD |
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| IRB Project Number: | STU00002932 |
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| Description of Research Trial: | This research study seekd individuals who have had a heart transplant over 6 months ago, and are being seen for standard post-transplant follow up. This study is being done to compare the safety and effectiveness of monitoring rejection using endomyocardial (heart) biopsies to that of a gene expression blood test. Investigators hope to learn if acute rejection of the transplanted heart can be safely monitored using a newly developed blood test so that repeated heart biopsies can be avoided. The blood test, called Gene Expression Profiling (GEP), identifies the expression of genes on white blood cells that circulate in the blood and cause the heart to be rejected. The study will be conducted in heart transplant patients who are more than six months out from their transplant because the probability of acute rejection is much lower during this time frame. Half of the subjects who agree to participate in this study will be randomly assigned to monitoring of their blood, at the standard of care follow up visits, depending on their time post-transplant, and will only have a heart biopsy if the blood test or clinical signs suggests that acute rejection may be occurring. The remainder of the subjects will have standard monitoring of acute rejection, which involves obtaining heart biopsies at standard of care intervals, depending on your time post transplant. Participation in this study will last approximately 2 years. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Karissa Fortney, MSN, BS, RN at (312) 926-4801or e-mail k-fortney@northwestern.edu |
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| Name of Research Trial: | Plasma Brain Natriuretic Peptide Response To Rapid Right Ventricular Pacing: The Initial Responses To Ventricular Pacing (IRVING) Study |
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| Principal Investigator: | Jason Jacobson, MD |
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| IRB Project Number: | STU00002760 |
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| Description of Research Trial: | This study is looking for patients that have a weakended left ventricle (lower chamber of the heart) and that also have a dual-chambered pacemaker or an ICD (implantable cardioverter-defibrillator). The purpose of the study is to determine the effects that single-chamber pacing and dual-chamber pacing have on the heart. Specifically, we will be measuring the levels of plasma brain natriuretic peptide (BNP) before, during and after a pacing procedure. BNP is produced by the heart and has been shown to be a sensitive and specific indicator of how hard the heart is working. Our goal is to identify patients which may benefit from one type of pacing versus another in an attempt to prevent the development of heart failure symptoms and hospitalizations for heart failure. These measurements may suggest ways to improve pacemaker/ICD treatment in patients with heart failure. Participation in this study will last for 6 months and will involve one study visit and a follow-up phone call. Compensation and parking will be provided. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact the principal investigator, Dr. Jacobson at jasonjacobson@nmff.org or by calling (312) 695-0054. |
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| Name of Research Trial: | CHAMPION: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (Protocol CM-06-04) |
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| Principal Investigator: | William Cotts, MD |
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| IRB Project Number: | STU00001613 |
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| Description of Research Trial: | This research study is looking for patients who have been diagnosed with heart failure (HF). Heart failure is a disorder that causes damage to the heart over a period of time. This damage makes it difficult for the heart to pump enough blood to meet the demands of the body. Heart failure is a progressive disease that often gets worse over time. The purpose of this study is to evaluate an investigational system developed for use in the medical management (helping your doctor decide what medications are best) of patients suffering from heart failure, the CardioMEMS® HF Pressure Measurement System. The study measurement system is not approved by the U.S. Food and Drug Adminstration (FDA) for treatment of patients with decreased heart function; therefore, its use in this study is considered experimental. The study measurement system consists of a sensor, delivery system, external electronics (antenna), and a home monitoring unit. The system will be used in your home to transmit your pulmonary artery pressure measurements to a secure website for your physician to review and determine the best way to manage your disease based on the information provided by the study measurement system. The study sensor will be implanted during a heart catheterization procedure and is placed inside your pulmonary artery (one of the vessels close to the heart) with a special catheter. Participation in this study will last approximately 3 years and will involve about 10 visits. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Trocchio at (312) 695-0045 or e-mail w-trocchio@northwestern.edu |
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| Name of Research Trial: | Harefield Recovery Protocol (HARPS) Study: A Non-Randomized, Open Label, Multi-Center Evaluation of Potential Recovery of Heart Function in Patients with Refractory Chronic Heart Failure by Treatment with a Combination of Left Ventricular Assist Device (LVAD), Maximal Heart Failure Therapy, and the Beta-2 Adrenergic Receptor Agonist, Clenbuterol. |
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| Principal Investigator: | William G. Cotts, MD |
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| IRB Project Number: | STU00000744 |
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| Description of Research Trial: | This research study is looking for patients who are on the heart transplant list due to chronic end-stage heart failure and are scheduled to receive or have recently received a left ventricular assist device (LVAD). Heart failure occurs when the heart has become weak and cannot pump blood to the rest of the body as well as it should. In a healthy heart, the left ventricle pumps blood through the body. In a heart weakened by heart failure, the left ventricle is often not strong enough to pump the blood sufficiently. A LVAD is a mechanical pump that works along with the heart to provide additional pumping action. The purpose of the study is to evaluate if treatment with Clenbuterol (study medication) in patients with heart failure that have recently received an LVAD can improve heart function enough to have the LVAD removed and not need a heart transplant. The study medication is currently approved in Europe for treatment of asthma. It is not approved by the U.S. Food and Drug Administration (FDA) for treatment of patients with decreased heart function; therefore, its use in this study is considered experimental. Participation in this study will last approximately 2.5 years depending on how long you take the study drug and the severity of your heart failure symptoms. During the course of this study you will be seen monthly. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Trocchio at (312) 695-0045 or e-mail w-trocchio@northwestern.edu |
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| Name of Research Trial: | Pre-Discharged Assessment of Patients Admitted with Heart Failure (ASSESS-HF) Study |
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| Principal Investigator: | Mihai Gheorghiade, MD |
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| IRB Project Number: | 0220-028 |
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| Description of Research Trial: | Individuals who are hospitalized with congestive heart failure (CHF) will be asked to participate in this study prior to their discharge from the hospital. After consent, information will be collected from the medical record, and a few additional simple noninvasive tests will be performed. Then twice in the first few months following discharge you and/or your family will be called and asked a few questions. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Dr. Gheorghiade at m-gheorghiade@northwestern.edu |
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