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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: | 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 Katherine Shelby, MPH at (312) 695-3264 or e-mail k-schelble@northwestern.edu |
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| Name of Research Trial: | US PARACHUTE: United States PercutAneous Ventricular RestorAtion in Chronic Heart FailUre due to Ischemic HearT DiseasE |
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| Principal Investigator: | Charles Davidson, MD |
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| IRB Project Number: | STU00003049 |
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| Description of Research Trial: | Patients with heart failure due to a previous heart attack have the opportunity to participate in this research study. This study will evaluate an investigational device called the CardioKinetix VPD Implant and Delivery System. The Ventricular Partitioning Device (VPD) make the inside of the heart smaller. The goal of the device is to improve the function of the heart by changing it back to a more normal size and shape. The device is placed percutaneously (through the skin) via a small tube in the groin. The purpose of the study is to determine the safety and feasibility of using this device. Participation in this study will last for 5 years and will involve several follow-up clinic visits during the first year and annual follow-up visits thereafter up to 5 years. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Lynne Goodreau, RN at (312) 926-5855 or e-mail lgoodrea@nmh.org or Jennifer Lagman, RN at (312) 926-9132 or email jlagman@nmh.org |
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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 Kathy Schelble at (312) 695-3246 or e-mail kschelbl@nmh.org |
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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 Marci Worley, RN, Clinical Research Nurse at (312) 695-0045 or e-mail m-worley2@northwestern.edu |
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| Name of Research Trial: | A Randomized, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Rivaroxaban in Subjects with Acute (Open-Label, Active, Controlled) or Chronic (Double-Blind, Placebo-Controlled) Congestive Heart Failure |
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| Principal Investigator: | Michelle Montpetit, MD |
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| IRB Project Number: | STU00002441 |
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| Description of Research Trial: | In this research study we want to evaluate what the body does to the study drug, what the study drug does to the body, and what adverse reactions, if any, may result from taking the study drug. These parameters have been studied in other subject populations, and will be compared to subjects with acute CHF (subjects who are currently hospitalized) and subjects with chronic CHF (subjects who are treated at home). The study team will evaluate the results and also determine if the dosage of the study drug should be increased or decreased from 10 mg per day. Depending on when a subject enters the study, they may be in a group of additional subjects receiving the study drug at a different dosage. While individuals take part in this study, they cannot take part in any other medical research studies. This study will evaluate two groups of subjects with CHF; those with acute and chronic heart failure. |
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Research Trial Contact Information: | For more information, interested participants and clinicians may contact Marci Worley, RN, Clinical Research Nurse at (312) 695-0045 or e-mail m-worley2@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: | John O'Connell, 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 Marci Worley, RN, Clinical Research Nurse at (312) 695-0045 or e-mail
m-worley2@northwestern.edu |
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| Name of Research Trial: | Evaluation of the VentrAssist™ Left Ventricular Assist Device as a Bridge to Cardiac Transplantation |
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| Principal Investigator: | Edwin McGee, Jr., MD |
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| IRB Project Number: | STU00001622 |
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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 VentrAssist™ Left Ventricle Assist Device (LVAD), as a treatment for end stage heart failure patients who require circulatory assistance while waiting for a heart transplant. The VentrAssist LVAD is a mechanical blood pump that is implanted in the body to assist the heart pump blood around the body. This is an experimental device, which means it is not yet approved by the Food and Drug Administration (FDA) in the United States. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Charity Ball, RN, Clinical Research Coordinator at (312) 926-5517 or e-mail cball@nmh.org |
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| Name of Research Trial: | Evaluation of the VentrAssist™ Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy; Procotol No CLP 12082 |
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| Principal Investigator: | William G. Cotts, MD |
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| IRB Project Number: | STU00001672 |
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| Description of Research Trial: | This research study is looking for patients who are have advanced heart failure symptoms and are not eligible for cardiac transplantation. The purpose of this clinical research study is to evaluate the safety and effectiveness of a new heart assist device, known as VentrAssist™ Left Ventricular Assist Device (LVAD), in providing long-term circulatory support for patients who have advanced heart failure symptoms and are not eligible for cardiac transplantation. The VentrAssist ia a small (about 6cm or 2¼ inches in diameter) lightweight (about 300 grams or 10½ ounces) blood pump which was designed to be surgically implanted (placed) in the body to assist the main pumping chamber of the heart, called the left ventricle. The VentrAssist is an experimental device, which means it is not yet approved by the Food and Drug Administration (FDA) in the United States. Heart failure symptoms can reach a point where you may be a candidate for LVAD implantation as long-term therapy (known as Destination Therapy). An LVAD is used to help support the body's blood circulation (flow). Because the heart cannot pump strongly enough to adequately circulate (move) the blood, an LVAD will take over the pumping function of the left ventricle. An LVAD does not replace the heart but works along with the heart to help pump blood. The performance of the VentrAssist device will be compared to the best available alternative therapy, which may also include an LVAD that has already been approved for this use by the FDA. |
| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Charity Ball, RN, Clinical Research Nurse at (312) 926-5517 or e-mail cball@nmh.org |
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| Name of Research Trial: | Post-transplant antibody and chronic heart allograft rejection: A multi-center study |
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| Principal Investigator: | William G. Cotts, MD |
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| IRB Project Number: | STU00001744 |
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| Description of Research Trial: | This research study is looking for patients who are about to receive or have recently received 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. We do not always know why some transplants last longer than others. Recent studies have shown that certain antibodies (a type of protein released by the body's immune system to fight off foreign substances that may be a threat to the body) may cause heart transplants to fail. Approximately 70 institutions are particpating in this study. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Marci Worley, RN, Clinical Research Nurse at (312) 695-0045 or e-mail
m-worley2@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: | John O’Connell, 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 Charity Ball, RN, Clinical Research Nurse at (312) 926-5517 or e-mail cball@nmh.org |
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| Name of Research Trial: | WBC Trial: Who Benefits from Cardiac Resynchronization Therapy? |
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| Principal Investigator: | Jeffrey Goldberger, MD |
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| IRB Project Number: | 0225-044 |
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| Description of Research Trial: | This research study is looking for patients who are scheduled to have a Cardiac Resynchronization Therapy (CRT) device implanted for treatment of their heart failure. The CRT Device is already approved by the Food and Drug Administration (FDA) as a treatment for patients with heart failure. The purpose of this study is to evaluate different tests that may be able to predict how well a patient responds to CRT. These tests include Tissue Doppler Imaging (TDI), Cardiac Magnetic Resonance Imaging (cMRI) and Echocardiography (Echo) testing. These are routine tests ordered by physicians in clinic. By collecting information from these tests, doctors may be able to determine which patients do not respond well to CRT and provide them with closer monitoring. Participation in this study will last 6 months and will require 2 outpatient visits. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Heather Kleinschmit, RN at (312) 926-9413 or e-mail h-kleinschmit@northwestern.edu |
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| Name of Research Trial: | What is Bradycardia in Patients with Congestive Heart Failure? |
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| Principal Investigator: | Jeffrey Goldberger, MD |
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| IRB Project Number: | 0225-018 |
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| Brief Description of Research Trial: | This trial is looking for two groups of patients: (1) patients who have a pacemaker and normal heart function who have been diagnosed with bradycardia (a condition that causes a slower than normal heart rate) and (2) patients with moderate to severe heart failure who have a pacemaker. The purpose of this study is to determine at what heart rate the heart functions best. Participation in this study will involve one outpatient visit that will last approximately 2 hours. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact the study coordinator, Katie Small at (312) 926-2773 or e-mail at ksmall@nmh.org |
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| Name of Research Trial: | Parasympathetic Tone During Exercise |
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| Principal Investigator: | Jeffrey J. Goldberger, MD |
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| IRB Project Number: | 0225-019 |
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| Description of Research Trial: | This research study is looking for individuals that have a permanent pacemaker or implantable defibrillator. The purpose of this research study is to investigate the nervous system's control of the heart during exercise. Participation in this study will last 4 days and will require 4 separate outpatient visits. On days 1 and 2 visits will last approximately 1.5 hours. On days 3 and 4 visits will last between 3 and 4 hours. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Alex Chicos, MD at (312) 916-1586 |
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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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