Research Trials in the Center for Heart Failure

IMPROVE-HF Bridge Pilot Study

The IMPROVE-HF trial is recruiting patients who have been admitted to the hospital for heart failure.  The purpose of this clinical research pilot study is to assess how heart failure patients are managed by primary care physicians and cardiologists (physicians that specialize in the heart) from hospitalization through six (6) months according to American College of Cardiology (ACC) and American Heart Association (AHA) heart failure (HF) guidelines. Heart failure guidelines are recommended procedures for physicians on treating patients that have been diagnosed with having heart failure.  

Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation (Echo-CRT)

The EchoCRT study is recruiting people who have heart failure and require an implantable cardioverter defibrillator (ICD) for the treatment of fast, irregular heart rhythms in the lower chambers of the heart (“intraventricular dyssynchrony”).  When the heart beats too fast, it is unable to pump enough blood to the rest of the body.   An ICD can give therapy to stop the fast heart rates and help the heart beat regularly.  For some cases of heart failure, doctors may consider an ICD that can also provide pacing therapy (small electrical impulses), called Cardiac Resynchronization Therapy (CRT.) This treatment may help the heart contract in a more efficient way and may improve heart failure symptoms.

Whether CRT will help a patient with heart failure can be determined in different ways. The traditional way is to consider symptoms as well as the results of an electrocardiogram (ECG), which shows the electrical activity of the heart.  In order for the heart to pump blood, an electrical pulse travels through the heart causing different parts of the heart to contract at different times.  An ECG makes a graphic which records this electrical activity. Some recent studies have shown that people who have symptoms of heart failure, but do not have this kind of delayed electrical conduction shown on an ECG, may also benefit from CRT.  A test called an echocardiogram (or “echo”) can offer additional information about how efficiently the heart is pumping blood by using sound waves to produce an image of the beating heart. 

The purpose of this study is to determine if CRT can prevent death or reduce heart failure hospitalizations for patients who have dyssynchrony as shown by an echocardiogram, but don’t have delayed pulse conduction shown on an ECG.  Although the device and leads used in this study are FDA-approved, this is an investigational study because CRT is being evaluated for its possible benefit in a new group of people with heart failure rather than those for whom it is usually prescribed.

Approximately 1250 subjects will be enrolled in the study at up to 125 sites in the United States, Europe, Australia, and Canada.  We hope to enroll up to 30 subjects here at Northwestern University. 

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

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).   

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

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.

Effects of Ranolazine in Patients with Angina Due to Right Ventricular Ischemia in Pulmonary Arterial Hypertension

This research study is looking for patients with pulmonary artery hypertension that experience chest pain (angina) or symptoms that suggest there is reduced blood flow to the heart.  Pulmonary Hypertension (PH) is a disease of the blood vessels in the lungs and starts when small blood vessels tighten up and become narrow.  As a result, the heart must work harder to push the blood through the narrowed blood vessels, resulting in an increased pressure in the lungs and increased stress on the heart.  As the disease progresses, less blood is able to flow out of the heart, through the lungs, and into the body, and more symptoms (such as shortness of breath, fatigue, chest pain) begin to appear.

The purpose of the study is to determine if using the medication, ranolazine, for three (3) months can help improve the heart's ability to pump blood, increase exercise capacity and improve quality of life (QOL) in patients with PH.  Ranolazine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of angina, but is considered experimental for treating PH in this study.

Evaluation of the HeartWare Left Ventricular Assist Device System for the Treatment of Advanced Heart Failure

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.

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

TOPCAT - Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist

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.