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Research Trials in the Center for Heart Failure

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.

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.  The following clinical research trial(s), specific to heart failure, are currently recruiting volunteers:

A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

Principal Investigator:
Edwin McGee, Jr., MD (profile opens in new window)
IRB Project Number:
STU00085145
Description of Research Trial:

This research study is looking for patients who have advanced heart failure symptoms and are not eligible for cardiac transplantation.

The purpose of this study is to determine the stroke risk associated with the left ventricular assist device (LVAD), the HeartWare® Ventricular Assist Device System (HVAD), in treating the condition of chronic heart failure and to test the hypothesis that stroke can be managed by physicians through enhanced blood pressure management.  An LVAD is a mechanical pump that connects to your heart and assists it by taking over some of the work of pumping blood.  The LVAD will assist your heart to provide your body with blood flow which is necessary to live.

There are two LVADs in the study:  the HeartWare® VAS, the study device, which is investigational, meaning that it is not yet approved by the U.S. Food and Drug Administration (FDA); and the HeartMate II® Left Ventricular Assist Device (LVAD) which has been approved by the FDA for Destination Therapy. 

Chronic advanced heart failure is a condition in which a heart cannot pump enough blood to the body's organs.  People with heart failure cannot exert themselves because they become short of breath and tired.  With chronic advanced heart failure, cellular malnutrition can occur with symptoms of tissue wasting and weight loss.  Heart failure symptoms can reach a point where a patient becomes 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 “study device” and approved LVAD are battery-operated, mechanical pump-type devices that are surgically implanted.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact Katherine Benes at (312) 694-0509 or e-mail kbenes@nmh.org

A Multicenter, International, Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of Daily Oral Dosing of Tafamidis Meglumine (PF-06291826) 20 mg or 80 mg in Comparison to Placebo in Subjects Diagnosed With Transthyretin Cardiomyopathy (TTR-CM)

Principal Investigator:
Sanjiv Shah, MD (profile opens in new window)
IRB Project Number:
STU00086536
Description of Research Trial:

This study is recruiting subjects that have a diagnosis of transthyretin amyloid cardiomyopathy (TTR-CM).  The condition causes accumulation of a protein in the heart and increases the risk of having heart problems.  To be eligible for this study, participants must have had medical evidence of prior Heart Failure.

The purpose of this research study is to compare the effects over 30 months of the study drug, tafamidis meglumine (hereafter called tafamidis) at two different doses (20 mg and 80 mg) with placebo to find out which is better for treating TTR-CM.  Participants will remain on their current standard treatment for their condition.  A placebo looks like the study drug but does not contain any drug.  Researchers use a placebo to see if the study drug works better or is safer than not taking the study drug.

Tafamidis is a study drug that is being tested for the treatment of transthyretin amyloidosis, specifically targeting forms of the disease with either nerve or heart impairment. Tafamidis (Vyndaqel®) is approved in Europe by the European Medicines Agency (EMA) and is available by prescription for Transthyretin Familial Amyloid Polyneuropathy (a condition which results in damage to nerves).  However, the use of tafamidis in this study is investigational.  It is investigational because tafamidis is not currently approved to treat TTR-CM.

For those who complete the entirety of this 30-month study, the option will be provided to participate in an extension study with tafamidis treatment.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Hamorabi Mkrdichian at (312) 926-2773 or e-mail hmkrdich@nmh.org

Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (The COAPT Trial)

Principal Investigator:
Mark Ricciardi, MD (profile opens in new window)
IRB Project Number:
STU00064006
Description of Research Trial:

The COAPT Trial is recruiting patients who have moderate-to-severe or severe functional mitral regurgitation (FMR) and have been determined to be at high risk for traditional mitral valve surgery.  FMR occurs when the two leaflets of the mitral valve do not close properly, causing blood to leak backward with each heartbeat.  Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.

The purpose of the study is to evaluate (study) the safety and effectiveness of the MitraClip System (“Study Device”) in patients with of mitral regurgitation (MR) that are at high risk for mitral valve surgery.  The Study Device consists of an implantable clip to repair the mitral valve and a delivery catheter (a thin, flexible tube through which the clip is passed into the body).  The Study Device has not been approved by the US Food and Drug Administration (FDA) for use outside of research trials, and is considered experimental in this study.

This is a randomized study which means that there is a 50/50 chance (like flipping a coin) of being assigned to receive the study device or not.  Subjects assigned to the Control (no Device group) may be eligible to receive the Study Device after their 2 year study visit. 

Up to 420 patients at 75 medical centers in North America will participate in this clinical study. We hope to enroll up to 20 participants here at Northwestern.

Participation in the study will last up to 5 years.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact Kate Jordan at (312) 926-0840 or e-mail kjordan@nmh.org 

AC6: Ad5.hAC6 Gene Transfer for CHF

Principal Investigator:
Clyde W Yancy, MD (profile opens in new window)
IRB Project Number:
STU00045282
Description of Research Trial:

This research study is looking for patients diagnosed with congestive heart failure (CHF). The purpose of this research study is to find out 1) whether a study treatment called gene transfer using an investigational agent called Ad5.AC6 (adenovirus-5 encoding (adenylyl cyclase type 6) can be given safely to persons subjects (or people) with congestive heart failure and 2) whether this agent may be of benefit in heart failure.

Gene transfer means that genes are introduced into cells within the subject’s body and the cells then produce the specific protein that the gene directs, in this case, a protein known as adenylyl cyclase type 6 (AC6). In animal experiments, it was found that increased amounts of AC6 protein in heart cells appeared to make the heart pump more vigorously.  The gene is carried into the subject’s heart cells by a modified (changed) virus.  The virus that has been changed is an adenovirus (Ad5), a virus that sometimes causes a brief cold. The adenovirus is changed so that it cannot reproduce itself and therefore is far less likely to cause an infection. 

This is a phase I/II study which means that this agent, Ad5.hAC6, is investigational and not approved for use by the Food & Drug Administration (FDA). A phase I/II study is set up to look at the safety and effectiveness of a new drug.  Patients will be assigned to receive either one of two groups:  Ad5.AC6 or placebo (inactive substance).  There is a 75% chance of receiving Ad5.AC6 and a 25% chance of receiving placebo and there is a three in four chance that a subject will be on the Ad5.AC6 arm of treatment.

Participation in this study will last for about 12 months, with most of the visits being in the first 12 months, and a follow up telephone calls made 2 and 3 years after enrollment on month 24 and month 36. The total number of study visits over the first 14 months will be about 16 visits. There may be an instance in which a study visit will need to be split into two separate days and this may increase the total number of study visits.

Fifty-six subjects will take part in this study at 4 study centers including Northwestern University.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Dan Roshevsky at (312) 695-3264 or e-mail droshevs@nmh.org

AVOID-HF: Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure

Principal Investigator:
Robert Gordon, MD (profile opens in new window)
IRB Project Number:
STU00066498
Description of Research Trial:

The AVOID-HF trial is recruiting Heart Failure patients who have been admitted to the hospital for treatment of excess fluid in the lungs or legs.

When patients come to the hospital with too much fluid, they can be given a liquid diuretic through a needle into a vein in the arm, (“IV diuretics”).  Treatment with IV diuretics can work very well to remove fluid from the body; however, the response may vary from person to person.  Another way to remove the extra fluid from the body is called aquapheresis therapy (also called “blood filtration” or “ultrafiltration”).  This method removes a little bit of water from the blood through a filter over time. Aquapheresis therapy for this study will be done with the Gambro UF Solutions, Inc. (formerly known as CHF Solutions, Inc.) Aquadex FlexFlowTM System (“Study Device”).  The Study Device and aquapheresis therapy are approved by the Food and Drug Administration (FDA).  

The purpose of the research is to learn if patients who have received aquapheresis therapy have fewer Heart Failure events (i.e. having to go back to the hospital or emergency room to be treated for Heart Failure) compared to patients who have received IV diuretics.  Also, the study will look at quality of life for heart failure patients that have received aquapheresis therapy or IV diuretics.

A total of 810 patients will take part in this study at a minimum of 25 study sites in the United States.  We plan to enroll up to 20 participants here at Northwestern.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Maggie McCarthy at (312) 926-9874 or e-mail mmccart3@nmh.org or Susan Herman at (312)926-9769 or e-mail sherman2@nmh.org 

Mechanical Circulatory Support: Development & Use of Quality of Life Instruments

Principal Investigator:
Kathleen Grady, PhD/RN (profile opens in new window)
IRB Project Number:
STU00066200
Description of Research Trial:

The purpose of this study is to develop a questionnaire, to assess health-related quality of life (HRQOL), to help evaluate the impact of mechanical circulatory support (MCS) devices on heart failure patients who receive these devices. As MCS technology evolves, survival is expected to improve, and the risk of adverse events is expected to decrease.  However, future use of devices will depend not only on survival and the risk of adverse events, but also on HRQOL, which is less well defined. We believe that this questionnaire will help standardize HRQOL information received from patients and their caregivers about these devices and support patients and physicians in the treatment decision-making process.

The study is looking for participants who are either:

  • Going to receive, or have received, a mechanical circulatory support device (MCSD)

OR

  • A caregiver for a patient who is going to receive, or has received, a mechanical circulatory support device (MCSD)
The study will involve interviews with up to 15 participants who are going to receive a MCSD, 40 participants who have received a MCSD, and 20 caregivers for patients who have received a MCSD.
Research Trial Contact Information:

For more information, interested participants and clinicians may contact the Clinical Trials Unit at (312) 926-4000 or e-mail heartresearch@northwestern.edu 

Left Atrial Pressure Monitoring to Optimize Heart Failure (LAPTOP-HF)

Principal Investigator:
Robert Gordon, MD (profile opens in new window)
IRB Project Number:
STU00038186
Description of Research Trial:

This research study is looking for patients diagnosed with heart failure (HF).  Patients with HF have blood that moves through the heart and body at a slower rate causing increased pressure in the heart. As a result, the heart cannot pump enough oxygen and nutrients to meet the body's needs. The chambers of the heart respond by stretching to hold more blood to pump through the body. This helps to keep the blood moving, but in time, the heart muscle walls weaken and are unable to pump as strongly.  Eventually, the following symptoms may develop: shortness of breath, swelling of the feet and legs, dizziness, fatigue and weakness, reduced exercise capacity and irregular heartbeats. Doctors use these symptoms to evaluate the severity of HF and help determine doses of medications for their patients.  However, by the time symptoms occur, some patients may need to be hospitalized to control their HF.

The purpose of this study is to evaluate the safety and effectiveness of an investigational device intended to treat HF. The Left Atrial Pressure (LAP) Monitoring Systems is designed take readings of the blood pressure within the heart.  These readings may help physicians decide if changes are needed to medications before patients develop symptoms or require hospitalization.  The information collected will be evaluated to see if subjects with the study device have less heart failure related hospitalizations than those who do not have the study device. Approximately 730 subjects will be enrolled in the study at up to 75 sites in the United States.

The LAP Monitoring System is investigational in the United States and has not been approved by the United States Food and Drug Administration (FDA).   

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Dan Roshevsky at (312) 695-3264 or e-mail droshevs@nmh.org

Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure

Principal Investigator:
Edwin McGee, Jr., MD (profile opens in new window)
IRB Project Number:
STU00034698
Description of Research Trial:

This study is looking for patients who have advanced heart failure symptoms and are not eligible for cardiac transplantation.

The purpose of the study is to determine the safety and effectiveness of a left ventricular assist device (LVAD), the HeartWare® VAS study device, in treating the condition of chronic advanced heart failure.  There are two LVADs in study: the HeartWare® VAS, the study device, which is investigational, meaning that it is not yet approved by the U.S. Food and Drug Adminstration (FDA); and the HeartMate II® Left Ventricular Assist Device (LVAD) which has been approved by the FDA for Destination Therapy.

Chronic advanced heart failure is a condition in whch a heart cannot pump enough blood to the body's organs.  People with heart failure cannot exert themselves because they become short of breath and tired.  With chronic advanced heart failure, cellular malnutrition can occur with symptoms of tissue wasting and weight loss.  Heart failure symptoms can reach a point where a patient becomes 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 "study device" and approved LVAD are battery-operated, mechanical pump-type devices that are surgically implanted.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Katherine Benes at (312) 694-0509 or e-mail kbenes@nmh.org

A Global, Multi-Center, Longitudinal, Observational Survey of Patients with Documented Transthyretin (TTR) Mutations or Wild-Type TTR Amyloidosis

Principal Investigator:
Sanjiv Shah, MD (profile opens in new window)
IRB Project Number:
STU00004191
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.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact Hamorabi Mkrdichian at (312) 926-2773 or e-mail hmkrdich@nmh.org
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This page last updated 

February 11, 2014
Feinberg School of Medicine home page

Bluhm Cardiovascular Institute - Clinical Trials Unit (CTU)
Feinberg School of Medicine
676 North Saint Clair Street, Suite 1700
Chicago, IL 60611-2969
Phone: (312) 926-4000
Email: heartresearch@northwestern.edu

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