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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 randomized, parallel-group, placebo-controlled, double-blind, multi-center dose finding phase II trial exploring the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the oral sGC stimulator BAY 1021189 over 12 weeks in patients with worsening heart failure and preserved ejection fraction (HFpEF) 

Principal Investigator:
Sanjiv Shah, MD (profile opens in new window)
IRB Project Number:
STU00090022
Description of Research Trial:

This study is recruiting subjects that have chronic heart failure.

The purpose of this study is to investigate the efficacy and safety of an investigational medication, BAY 1021189 (the study drug) in subjects with heart failure. The study drug (BAY 1021189) is considered investigational because it has not been approved by the US FDA (US Food and Drug Administration).

The study drug belongs to a class of medications called ‘sGC stimulators’ (soluble guanylate cyclase stimulator) and is being developed as a potential new treatment for heart failure. Heart failure means that the heart has lost some of its capacity to pump blood around the body sufficiently. In heart failure the body is deficient in a natural chemical called nitric oxide which binds to a special protein (‘receptor’) called sGC. This lack of stimulation of sGC causes changes to the body’s blood vessels and affects how organs function, including the heart. The study drug works by stimulating nitric oxide, which in turn may restore sGC activity and help improve the heart’s function.

Up to 470 study subjects will take part in the study in roughly 20 countries. We hope to enroll up to 3 subjects at Northwestern.

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 or Leah Canvasser at (312) 926-2884 or e-mail lcanvass@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 or Leah Canvasser at (312) 926-2884 or e-mail lcanvass@nmh.org

Nitrate’s Effect on Activity Tolerance in Heart Failure with Preserved Ejection Fraction:  NEAT-HFpEF

Principal Investigator:
Sanjiv Shah, MD (profile opens in new window)
IRB Project Number:
STU00093689 
Description of Research Trial:

This study is recruiting subjects that have diastolic heart failure.

The purpose of this study is to determine whether a medicine called isosorbide mononitrate (ISMN) improves the symptoms and the ability to tolerate activity in people with diastolic heart failure.  This study will involve the use of ISMN which is currently used to prevent chest pain. The use of ISMN in patients with systolic heart failure is FDA approved, however its use with diastolic heart failure is investigational, meaning it is not part of regular medical care. ISMN has been shown to improve the symptoms of another type of heart failure called systolic heart failure.  Since the disease process is different between diastolic heart failure and systolic heart failure, we do not yet know whether ISMN will help people with diastolic heart failure.   

Diastolic heart failure is a condition in which one of the chambers of your heart – the left ventricle – is unable to relax completely and cannot fill with blood properly. This can cause you to be short of breath and can limit your ability to exercise which may impact your quality of life.

Approximately 100 study participants at approximately 20 clinical centers in the United States and Canada. We hope to enroll up to 10 subjects at Northwestern.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Leah Canvasser at (312) 926-2884 or e-mail lcanvass@nmh.org

Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT) 

Principal Investigator:
Sanjiv Shah, MD (profile opens in new window)
IRB Project Number:
STU00091566
Description of Research Trial:

This study is recruiting subjects that have congestive heart failure.

The purpose of this study is to determine the benefits and safety of liraglutide (study drug) in patients with acute heart failure syndrome. Liraglutide (commercial name Victoza®) is already approved by the U.S. Food and Drug Administration (FDA) for patients with type II diabetes, but its use in patients with acute heart failure is investigational.   

Congestive heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Patients hospitalized for an acute worsening of their heart failure are at increased risk for future adverse outcomes. To date, therapies added at the time of an acute heart failure episode have not improved patient outcomes. Recent studies suggest that improvements in the ability of the heart to use energy (metabolism) may help patients with heart failure. Because the study drug may improve how the heart uses energy, this study is evaluating if use of the study drug may help patients with heart failure.

Approximately 300 study participants at approximately 30 clinical centers in the United States and Canada. We hope to enroll up to 10 subjects at Northwestern.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Jessica Corona-Cox at (312) 926-2655 or e-mail jcoronac@nmh.org or Hamorabi Mkrdichian at (312) 926-2773 or e-mail hmkrdich@nmh.org 

PARACHUTE IV: PercutAneous Ventricular RestorAtion in Chronic Heart failUre due to Ischemic HearT DiseasE

Principal Investigator:
Charles Davidson, MD (profile opens in new window)
IRB Project Number:
STU00088640 
Description of Research Trial:

The purpose of the PARACHUTE IV study is to test the safety and effectiveness of a new device for the treatment of heart failure. “Heart failure” is a term used to describe a heart that gets sick or weak over time.  Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, impaired thinking, and increased heart rate. Heart failure means the heart is working harder and pumping more frequently to try and make up for not pumping effectively (well).  Over time, this increased workload of the heart may lead to a change in the heart known as remodeling. Remodeling is the enlargement and thinning of the heart’s left ventricle (main pumping chamber).  Left ventricular remodeling damages the heart over time and leads to more severe heart disease.

Many patients with heart failure take a combination of drugs that treat the symptoms of heart failure, but not the underlying cause - remodeling.  One method doctors use to treat patients with remodeling is by patching the heart using a procedure called Surgical Ventricular Restoration or SVR.  The patch procedure is an open-chest operation that removes the area of the heart muscle that is damaged to reduce the size of the ventricle.  The goal of the SVR patch is to restore the heart to a more normal size and shape to allow it to work better.  SVR surgery is a seldom-used operation, and the results have not been studied in large scientifically rigorous trials.

The Parachute device was developed to make the interior (inside) of the left ventricle smaller, similar to the SVR patch used in surgery.  The study device is placed into the ventricle using a catheter (a small hollow tube) inserted into an artery in the groin, eliminating the need for open-heart surgery.  The goal of placing the study device in the heart is the same as the surgical patch procedure – to improve the function of the heart by changing it back to a more normal size and shape. The Parachute Implant is an investigational device, which means it is not approved for use by the U.S. Food and Drug Administration (FDA). 

The Parachute Implant procedure involves undergoing a standard echocardiogram and Cardiac CT procedure to evaluate your heart and verify you are eligible to participate, then you will be randomly (similar to a flip of a coin) assigned to either receive the Parachute Implant or not.  Half of the patients enrolled into the study will receive the Parachute Implant and half will not (those patients will be part of the “control” group).  

Participation in this study will last for 5 years and requires a 6 month and annual follow-up visits to the doctor out through 5 years. The tests and procedures that are done specifically for this study will be covered by the sponsor, including the cost of the study device and placement of the study device. Participants will be paid $50 for each study visit completed.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Leah Brousalis at (312) 926-9874 or e-mail lbrousal@nmh.org

A Phase IIa single blind, placebo-controlled, crossover, multi-center, randomized study to assess the safety, tolerability, and preliminary efficacy of a single intravenous dose of human allogeneic mesenchymal bone marrow cells to subjects with heart failure of non-ischemic etiology. “STEM-104-M-CHF”

Principal Investigator:
Allen Anderson, MD (profile opens in new window)
IRB Project Number:
STU00095028 
Description of Research Trial:

This study is recruiting patients with non-ischemic heart failure (decreased heart function). This is a type of heart failure that is not caused by coronary heart disease or heart attack. 

The main purpose of this study is to determine the safety and tolerability of a new investigational product, called aMBMC (“Study Drug”), in participants with non-ischemic heart failure. The second purpose of the study is to evaluate the effect that aMBMC has on the structure and function of the left ventricle (left lower heart chamber).

The Study Drug is made from human allogeneic mesenchymal bone marrow cells (aMBMC).  These cells are taken from the bone marrow of healthy adult people who volunteered to donate their cells (not from embryos) then the cells are grown in an FDA-approved manufacturing facility. These types of stem cells are being tested for conditions such as stroke, spinal cord injury, Alzheimer’s, Parkinson’s and other neurological diseases. Stem cells have the ability to become one or several different types of cells, and may repair damaged and/or replace lost cells in the body due to disease. The types of stem cells used in this study have been administered to numerous patients over the past 20 years. Administration of the study product will be given through an intravenous (IV) line placed in your arm or hand. Researchers hope that treatment with the Study Drug may help to improve heart muscle function in patients with non-ischemic heart failure.

Currently the cells are considered to be an “Investigational Product”.  That means they have not been approved by the FDA or any other international agency as a treatment of non-ischemic heart failure.

Participation in this study will last for about 15 months and will involve about 12 visits. The tests and procedures that are done specifically for this study will be covered by the sponsor, including the study drug and screening tests. Participants will receive reimbursement for their time and travel expenses.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact Kelsey Christiansen at (312) 926-4801 or e-mail kchrist2@nmh.org 

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS‑6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (GS-US-361-1157)

Principal Investigator:
Sanjiv Shah, MD (profile opens in new window)
IRB Project Number:
STU00097825
Description of Research Trial:

You are being asked to take part in this research study because you have Hypertrophic Cardiomyopathy (HCM), a disease that affects the muscle of the heart. HCM is a condition in which the heart muscle becomes abnormally thick for no clear reason, which can make it harder for blood to enter and leave the heart, forcing the heart to work harder to pump blood.

The purpose of this study is to see if GS-6615 (the study drug) improves the symptoms of HCM and helps the heart work better.  The study drug (GS-6615) is considered investigational, as it has not yet been approved by the US FDA (US Food and Drug Administration).

This research study plans to enroll approximately 220 study participants at approximately 40-50 sites, including approximately 10 people from this institution.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Leah Canvasser at (312) 926-2884 or e-mail lcanvass@nmh.org

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

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 

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 

August 18, 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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