Congestive Heart Failure (CHF)

(4/14/09)- The results of two studies that were done in connection with the benefits of aerobic exercise programs for patients with stable heart failure indicated that the quality of life improved for them, but it did not prove that it prevented re-occurrence of the heart problem. The results of the studies were published in a recent edition of The Journal of the American Medical Association. The National Heart, Lung and Blood Institute sponsored the trials.

About 5 million Americans have heart failure, in which the heart fails to pump enough blood for the body's needs, and an estimated 500,000 cases are diagnosed each year. People who suffer from this disease have difficulty doing the simplest physical activities and are frequently hospitalized.

Dr. Christopher M. O'Connor, the principal investigator for the trial, and director of the Duke University Heart Center at the Duke University School of Medicine in Durham, N.C., said: "The message for the average heart failure patient is :'We believe there are benefits from exercise. Quality of life is important, and physical fitness is important."

The trial followed 2,331 stable heart failure patients from the U.S., Canada and France, with a median age of 59. About 70% of the patients were males. One group of patients remained on their usual medical care, while the other group was put on an aerobic exercise program in addition to their standard medical care.

The patients were followed for a 2 1/2-year period of time.

Exercise participants began by using a treadmill or stationary bicycle 15 minutes to 35 minutes three times a week, working up to 40 minutes five times a week.

Death and hospitalization rates were only slightly lower in the exercise group. About 65%, or 759 patients, in the exercise training group died or were hospitalized, compared with 68%, or 796 patients, in the usual care group. Scientists determined that patients who exercised cut their risk of death and hospitalization by 11%.

(8/24/04)- NitroMed Inc. of Lexington, Mass. said it was halting a trial of its cardiovascular drug BiDil because the results were so favorable for black patients that black patients in the placebo group deserved to get the medication also. The Association of Black Cardiologists was a joint sponsor of the study. The study involved more than 1,000 patients in 170 U.S. sites.

The company said that it hoped to have the drug on the market by the first quarter of 2005 if the FDA approved the drug. There are an estimated 750,000 blacks with heart failure. In all, there are about 5 million Americans suffering from heart failure.

Heart disease in blacks is usually linked to hypertension rather than arterial blockages that are the major cause of the disease in white patients. According to NitroMed blacks are more likely to have a deficiency of nitric oxide, and the drug specifically addresses this issue.BiDil ia a combination of two old generic drugs, neither of them approved for heart failure. The FDA originally rejected the drug trials, with the proviso that further testing was needed for the combined generic drugs. This new trial was the one that was halted because of the positive results encountered in using the drug.

The FDA has approved Pfizer Inc.'s hypertension drug Inspra (eplerenone) for patients with congestive heart failure who have had a heart attack. It is estimated that about one-third of heart attack survivors develop heart failure. In clinical trials, patients who took Inspra along with standard therapies had a 15 % reduction in death compared with those who did not take Inspra. The FDA approved the drug last year for treating hypertension.

According to a study undertaken at the Columbia University College of Physicians and Surgeons in Manhattan, an implanted mechanical heart pump that assists but does not replace a failing heart, can significantly prolong the life and quality of life of a patient suffering from coronary heart disease. The study team was led by Dr. Eric A. Rose, who is chairman of the surgery department at the college.

The study found that the pump, known as a ventricular assist device (VAD) is superior to the most effective drugs being used to treat heart failure. About 500,000 Americans suffer from the advanced form of the disease, and nearly 50% of those who are afflicted will die within 5 years.

The risk of death in the study was 48% lower among patients who received the device than among those receiving the drug treatment. In addition to the survival rate being much higher for those receiving the assist pump, their quality of life was much better than those who were strictly on the drug regimen. The down side to this is however, is that the complication rate was 2.35 times higher for the assist device group than it was for the drug regimen group.

The device the study was tested on is called the HeartMate, which is made by a company named Thoratec of Pleasanton, Cal. There are several other assist devices being made by other companies. Don't confuse an assist device with the artificial heart replacement device made by AbioCor which has been in the news lately.

The survival rate was 52% for those receiving the assist device versus 24.7% for those on the drug therapy after one year. After two years the survival rate was 22.9% for those on the assist pump versus 8.1% for those on the drug regimen.

GlaxoSmithKline announced that the FDA has approved Coreg(R), (carvedilol) for the treatment of severe heart failure. Previous to this Coreg had already been approved for treatment of mild to moderate heart failure. Coreg, which is a beta-blocker, is therefore the only drug that has been approved for all three degrees of heart failure, namely mild, moderate and severe heart failure.

Centocor (Malvern, Pa.), a subsidiary of Johnson & Johnson, Inc. said that a Phase II trial of its Remicade infliximab to treat advanced congestive heart failure has been placed on hold. The preliminary data review of the trial showed no improvement in patients clinical status and a higher mortality in the Remicade group, especially at the higher dose of 10 mg/kg.

The FDA has approved Medtronic Inc.'s InSync device for U.S. marketing, which therefore makes it the first electrical device ever approved for the treatment of congestive heart-failure patients. The device is useful for only the 25% to 50% of those patients with an electrical malfunction called "left bundle branch block" that causes the heart's pumping chambers, the ventricles, to beat out of sync. It is now estimated that about 5 million American's suffer from congestive heart failure. Thus another option in the treatment of congestive heart failure becomes available in treating the disease.

Up until now nitroglycerin pills have been considered the primary drug used in cases of congestive heart failure. Natrecor, a new drug developed by a California biotechnology company named Scios is the first new drug for acute congestive heart failure that has been approved by the FDA in 14 years.

Two years ago an advisory panel gave approval to the same drug, Natrecor, but the FDA did not give the drug its final approval at that time. The FDA wanted further evidence as to the safety concerns that it had about the drug. The drug has been developed by a biotechnology company named Scios, which is based in Sunnyvale, Cal. Congestive heart failure affects about 5 million Americans. It is estimated that the Scios drug will be helpful to about 1 million Americans who are rushed each year to the hospital because they are barely able to breathe.

Natrecor was as effective as nitroglycerine in easing blood pressure and in improving the patients ability to breathe. Natrecor will cost $380 for a single daily dose while nitroglycerine costs between $10 to $15 per daily dosage. Congestive heart failure takes place when the heart is unable to pump enough blood to move oxygen and nutrients to all the body's organs and carry off waste, leading to fluid buildup in the body and the lungs. The new studies showed that Natrecor could restore blood circulation and reduce lung congestion in as little as 15 minutes.

Recently the Food and Drug Administration issued what the company called an " approvable" letter for Natrecor. The company indicated that they will meet the conditions imposed in the letter and hopes to win full approval of the drug by mid-August. Scios won't set the price for the drug until just before it is introduced, but the company said the price would be in the range of $250-$450 a day. Natrecor is a genetically enginered form of one of the body's own peptides which dilates arteries and veins. By dilating the veins and arteries it makes it easier for the blood to flow through them.

The FDA did not approve Natrecor the first time that it had been recommended to it because of fear that it reduced blood pressure too much in a small percentage of patients. It was also determined that a slightly higher percentage of patients were more likely to die. Scios executives argued that the differences were a result of chance. Natrecor is a genetically engineered version of a protein secreted by a failing heart. Scios executives stated that they expected final FDA approval in July. 

A number of our readers have directed questions to us about congestive heart failure. There appears to be some confusion about the meaning of this term. It does not mean that your heart has stopped functioning. What is happening is that the heart is not pumping blood as well as it should, and this results in fluid being built up in your body. The term "congestive" refers to the building up of fluids in the body.

There are multiple causes for this condition including the following:

The following list of symptoms of congestive heart failure is provided to make readers alert to the symptoms of a treatable disorder. Any of these symptoms should be called to the attention of your physician. Worrying because you experience one of the symptoms can bring on a cascade of somatic concerns that may prove more difficult to treat than the congestive heart failure. While working in collaboration with your physician, you can continue to enjoy a quality of life equivalent to what you had before the diagnosis, but with changes in your lifestyle and medication regimen.

Symptoms of Congestive Heart Failure

When you visit your treating physician, a series of tests will be given to check for congestive heart failure. These tests include blood tests, urine tests, chest x-ray, electrocardiogram (ECG) and an echocardiogram in which sound waves are used to get a picture of your heart in operation. Once your physician has the results of these tests, a working diagnosis will be made and treatment program will ensue.

You should remember that congestive heart failure is not totally curable. The treatment program is aimed at reducing the risk for further acute episodes of congestive heart failure. The treatment includes changes in lifestyle, such as eating a healthy diet while at the same time reducing the amount of salt intake, avoidance of alcohol, increasing exercise, ceasing smoking and losing weight.

The February 22, 2000 issue of Circulation carried the report of a meta-analysis of experiments done by researchers on the affect of lifting weights in people who had heart attacks. Weight lifting improves body composition and cardiovascular function. (Weight lifting is not for everyone. It is not recommended for individuals with unstable angina, uncontrolled high blood pressure, uncontrolled arrhythmia or those suffering heart failure.) This resistance training should be done along with aerobic workouts that includes brisk walking, bicycle riding and stretching.

Added to this regimen, your treating physician will probably put you on an appropriate medication. There are a wide range of drugs available to treat the various causes of congestive heart failure These drugs include ACE inhibitors and beta blockers which help open your arteries, lower your blood pressure and improve your blood flow. Diuretics called by many "water pills", will increase the frequency of urination and thus reduce the fluids in your system and enable you to breathe better. Digoxin (digitalis) will help the heart pump better. Nitrates are targeted to improve the flow of blood to the heart, as are beta-blockers as well as calcium channel blockers, which are discussed in the article "Beta-Blockers and ACE Inhibitors in the Battle against Heart Disease and Failure".

In regards to hestitancy to use beta-blockers, such as Coreg(R) for heart failure, we would like to cite Drs. Califf and O’Conner, writing in the March 8, 2000 issue of JAMA (283(19): 1335-1337), who stated:

"Given the overwhelming evidence of the benefits of b -blockers in patients with heart failure from this study and others. The current status of adopting this treatment into clinical practice must be examined. It would be difficult to make an argument that b -blockers should be withheld from any patient meeting the general criteria for entry into clinical trials. Yet, national and international data indicate that less than 30% of eligible patients are being treated.

Physicians can no longer accept the argument that absence of adequate knowledge is a reason for under use of b -blockers. The data are overwhelming and they have been published in leading medical journals…there is a large gap between the knowledge base about effective therapies and the appropriate delivery of these therapies."

These treatments can work, but it takes effort on part of the individual to maintain the treatment regimen and the physician to accept the evidence that they work.

A colleague has brought to my attention an article in the NY Times of March 23, 2000 entitled "A Simple Test Can Predict Heart Attacks" which describes an inexpensive test used to measure C-reactive protein in the blood stream. This is a substance, which indicates that arteries are inflamed. The belief is that inflamed arteries cause cholesterol deposits to break off and block flow of blood. This type of screening costs an average of $20 and could save many lives.

According to the preliminary results obtained by government researchers it was determined that patient's taking Pfizer's blood pressure drug Cardura were twice as likely to be hospitalized for congestive heart failure as those taking a generic diuretic drug. The advisory panel of the F.D.A. however determined that the agency should wait to inform doctors of these results until the agency had more information from the study. After making the finding, the researchers immediately halted the part of the study involving patients taking Cardura and offered them another medicine. The advisory panel agreed that the agency did not need to warn patients currently taking Cardura of the study's results. Even though the panel determined that the diuretic was more effective than Cardura in preventing heart failure, they did not think there was enough date to prove that Cardura was harmful.



Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated April 14, 2009

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