Information for Patients

This information is presented here for patients who may be candidates for enrollment in SCD-HeFT. Various aspects of the study are explained and many common questions that patients have about the study and heart failure treatment in general are answered.

What is SCD-HeFT?

Prevention of Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) is a five year clinical trial sponsored by the National Institutes of Health (NIH) through the National Heart, Lung, and Blood Institute (NHLBI). SCD-HeFT will study people with the clinical diagnosis of congestive heart failure (CHF), a condition of decreased or impaired function of the heart muscle due to disease. Patients with a diagnosis of CHF may be at a higher risk of an abnormal heart rhythm (arrhythmia) which can lead to sudden cardiac death (SCD). It is the goal of this study to test if a treatment for arrhythmias will decrease the risk of sudden cardiac death.

Why a clinical trial?

A clinical trial is a research study designed to answer an important medical question. Typically, a large number of people sharing the same medical problem are asked to enroll. Information is then collected to provide an insight to their medical conditions.

The investigators of a trial are trying to discover the best treatment for a certain medical condition. One way of doing this is to assign a treatment randomly, much like the flipping of a coin. Using this type of treatment selection process removes any bias or preference a doctor may have for or against a treatment. This will be the method used to decide which treatment you will receive if you decide to participate in SCD-HeFT. That is, you will be assigned one of the treatments being studied in a random fashion. The reason for assigning therapy this way comes from the knowledge that biases for or against a certain treatment have often been proven wrong. The way to discover what is best is to test the competing treatments in a scientific way by random assignment of treatments.

What will SCD-HeFT do for me?

Your doctor has already started your treatment for CHF. Based on the results of various tests, you are now taking certain medications to improve your heart's efficiency. With your CHF stabilized, you are eligible to enroll in SCD-HeFT.

SCD-HeFT will not alter any part of your heart failure treatment. That treatment continues as your doctor has ordered, and your doctor may make changes in your heart failure management as your condition changes. SCD-HeFT is not a treatment for your heart failure. Rather, it is evaluating treatments that may decrease the risk of sudden cardiac death.

There are two treatment arms in SCD-HeFT. One is a medication to control heart rhythms. The other is a special device called an implantable cardioverter-defibrillator (ICD) that treats abnormal heart rhythms when they occur. If you are enrolled in SCD-HeFT, you will be randomly assigned to one of these treatment arms.

We do not know if you will benefit from enrolling in SCD-HeFT. By agreeing to participate, you will provide valuable insight to a possible treatment to help people with CHF live longer and more productive lives.

How do doctors treat heart failure?

The treatment for heart failure includes changes in diet and physical activity as well as medications to reduce the symptoms of CHF.

Diet

When the heart is not able to provide sufficient circulation to meet your body's needs, many things can change within your body. With decreased circulation, your kidneys may not work as well as needed. This can lead to a retention of sodium (salt) and body fluids (edema). This edema can cause multiple changes to various body systems. These changes cause the symptoms most people associate with CHF, which include shortness of breath, easy fatigue, and a low energy level.

One of the ways you can reduce edema is through the careful choice of foods. Adding salt to foods can lead to increased edema. Therefore, carefully monitoring the amount of salt that is naturally contained in foods and reducing added salt is an important step in heart failure management. Reading labels on prepared foods and eating fresh fruits and vegetables - rather than canned or prepared foods - plays a big part in the management of CHF. Another way to help reduce edema is by limiting the amount of fluids that you drink. This includes all types of fluids, including water, juice, coffee, soft drinks, and soup. Talk with your doctor or nurse or ask for a consultation with a dietician about how fluids, foods, and food additives can affect heart failure.

If you smoke or drink, your doctor will also strongly encourage you to stop. This can be difficult for some but it is a very important step to take in managing heart failure.

Physical Activity

Staying physically active is an important aspect in the treatment of heart failure. Because of the heart’s decreased output, the heart cannot always supply enough circulation of blood to your body for the various activities it needs to do. Depending on how severe your heart failure is, an activity such as walking may be difficult. Therefore, it is important to know your limits and to recognize the symptoms of CHF. You and your doctor should talk about the types of physical activity you can do safely.

Medications

There are many medications that your doctor may prescribe to treat CHF. There are two basic types that are part of almost all heart failure treatments. One type is diuretics (water pills), a medication that helps the body get rid of extra fluid. The other type is vasodilators, a medication that helps to reduce blood pressure and, in turn, the work-load of your heart. Vasodilator therapy is the principal form of therapy for CHF and may be used alone or in combination with diuretics.

There are various kinds of each medicine type and many names for these medications. Your doctor and/or your nurse will discuss your specific medication needs. For the medication to work properly you must be sure that all of your medications are taken on time, in the right amount, and that you report back to your doctor the effects these medicines have on you and your symptoms.

How do doctors try to prevent sudden cardiac death?

A goal of therapies which treat abnormal heart rhythms is to prevent them from happening. One way is to decrease the ability of the heart to produce abnormal rhythms (arrhythmias) by giving a medication called an antiarrhythmic drug. This medicine suppresses the "automatic" nature of the heart that can cause abnormal heart rhythms. The medicine amiodarone (Cordarone), has been used for nearly 20 years. Over the years it has shown to be one of the most effective medications available for the treatment of life-threatening rhythm disorders. Previously, this drug was not started until the patient had an initial episode of an abnormal rhythm, that is, they survived a cardiac arrest. Studies have shown that if a person has one episode of such a rhythm, they are at a high risk of other episodes occurring.

Recent studies suggest that patients with symptoms of CHF may be at risk for serious heart rhythm problems. These studies have indicated that amiodarone may have a place in the prevention of abnormal rhythms, even before a "first episode" of an arrhythmia occurs. No study has demonstrated this benefit conclusively for patients with CHF.

A second method of managing abnormal heart rhythms is with an implantable cardioverter-defibrillator (ICD). An ICD is about the size of a credit card, only thicker. A doctor puts the ICD under the skin near the left shoulder. A catheter, a type of plastic coated wire, goes from the ICD to the heart through a vein under the collarbone. The ICD continuously monitors a patient's heart rhythm. If the heart slows down too much, the ICD will provide small electrical impulses to correct the rhythm. In this way the ICD is acting as a pacemaker. If the heart speeds up dangerously fast, the ICD will provide an electrical shock which corrects the abnormal rhythm. The ICD does not prevent an abnormal rhythm from starting, but it can stop one when one occurs. Like amiodarone therapy, ICD therapy is presently used only in patients who have survived a cardiac arrest.

How does SCD-HeFT work?

SCD-HeFT will enroll 2,500 people with CHF. These people will all have similar characteristics of heart failure. A method of evaluating the degree of heart failure is the New York Heart Association’s classification system for heart failure. This system rates heart failure, using classifications ranking from I to IV. Those rated I have minimal symptoms of heart failure. Those rated IV have the most severe symptoms of heart failure, some requiring chronic hospitalization. The classifications of class II and III are the individuals who will be included in SCD-HeFT. These are people with some of the chronic symptoms of heart failure that can be managed without hospitalization.

Joining SCD-HeFT is voluntary. If you decide to join, you will be in the study for at least 2 1/2 years and as long as 5 years, depending on when you enroll. When you enroll, you will have an equal chance of receiving any one of three treatments:

1. Conventional heart failure therapy
2. Conventional heart failure therapy plus the drug amiodarone (Cordarone)
3. Conventional heart failure therapy plus an ICD

The first two treatments make up the drug arms of the study. In addition to the conventional heart failure therapy, treatment 1 will also include a placebo (sugar pill). This pill will look the same as a Cordarone tablet, but it will not have any of the drug in it. Your doctor, nurse, and those involved with your care will not know if the pill is real drug or placebo. It is important to recognize that placebo therapy, i.e., conventional therapy, may be the best of the three approaches. We won’t know which is better until the study is over.

In the same way, the content of the pills in treatment 2 will not be known by your doctor. This information will be known only by the Data Coordinating Center staff at Duke University in North Carolina. This "blinding" provides the most reliable information about the effects of treatments. It decreases the chance of any bias affecting the information. However, if there is ever a need to know whether the pill is drug or placebo, your doctor will be told.

Those who receive an ICD enter the device arm of the study. After the ICD is placed under the skin in the left shoulder area, the ICD continuously monitors the heart's rhythm and "memorizes" any abnormal rhythms that a patient may have. On regular follow-up visits, a doctor or nurse will gather this information from the ICD using a computer-like device.

Patients who enroll in the study will continue to receive their regular heart medications and will continue to see their heart doctor. The study will make use of some of the information that is gathered during patient visits to the hospital or clinic. Some of this information includes reports of medical tests and procedures used to treat heart failure. Financial information about the costs of treating heart failure, including the costs of providing SCD-HeFT therapy, is gathered as well.

Most of the information needed for the study comes from regular hospital or clinic visits. However, there are at least two extra visits because of the study. These visits are necessary to be sure that the treatment for arrhythmias is not interfering with your heart failure treatment. Your study team will discuss these extra requirements with you in detail and provide you with a schedule of required visits. As before, because of your heart condition, you may need to have additional visits with your doctor to adjust your medications, etc.

There is no cost to you for participating in this study. The study drug or the ICD is provided without cost. The majority of the information needed for SCD-HeFT is available from your regular office visits. If the study requires special information, the costs of any necessary visits will be covered. However, you or your insurance company are responsible for the costs of managing your regular health care including your regular heart failure care.

Other information

If you decide to participate in SCD-HeFT, you will join a multicenter effort throughout the United States and Canada. This study could determine if there is a "best" therapy to help people like yourself to live longer and more productive lives. Your involvement will make this study successful. Enrolling in SCD-HeFT involves a commitment on your part to take all medications prescribed by your doctor, to make regular visits with your doctor and study coordinator, as well as you or your family keeping your doctor informed of any changes in your medical condition.

In turn, the SCD-HeFT investigators make this commitment to you: we will keep you informed of any significant findings in the treatment of heart failure and we will let you know of any information that might affect your willingness to continue participating in SCD-HeFT.

If you are enrolled in SCD-HeFT, you can decide to withdraw from the study at any time. Such a decision will not affect your regular heart failure care. Obviously, we hope that you decide to participate. However, we cannot help you with that decision. You and your family must make that decision together. But we will do all we can to answer any questions that you or your family may have.