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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: | 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 Karissa Fortney, MSN, BS, RN at (312) 926-4801or e-mail k-fortney@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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