Frequently asked questions

If you or someone you love has been diagnosed with heart failure (HF), you probably have a lot of questions about the condition, how it’s treated, and what you can do to manage it. Here are answers to the most commonly asked questions about HF.

General information about HF and how it's diagnosed

+What is heart failure (HF)?

Heart failure (HF) is when your heart is not pumping blood as well as it should. HF usually gets worse over time. Sometimes HF is called "congestive heart failure," which is when fluid buildup occurs.

+What causes HF?

HF is caused by other diseases or conditions that damage or overwork the heart. As a result, the heart's ability to pump blood weakens over time. Common causes of HF include
  • High blood pressure is another major cause of HF, especially among African Americans. When high blood pressure is not well controlled with proper medication, it puts extra strain on your heart and blood vessels with every beat. High blood pressure is 33% to 50% more prevalent in African Americans than in other American adults
  • Diabetes increases the heart's workload, especially if it is not regularly monitored and controlled with medication. Diabetes is associated with a higher prevalence of heart failure. About 60% more African Americans have diabetes compared with other ethnic groups
  • Coronary artery disease (CAD) is the most common cause of HF in America. In someone with CAD, the arteries that supply blood to the heart become narrow when a fatty substance called "plaque" builds up in the artery wall. (Some people take cholesterol-lowering medicines to prevent or treat this plaque buildup.) Plaque can block the flow of blood and oxygen to the heart, leading to chest pain (angina) or heart attack
  • A heart attack places you at high risk for HF. When a heart attack happens, part of the heart actually becomes permanently damaged. The healthy heart tissue that remains must pump even harder to keep up. This increased workload can lead to a loss of function

Other causes of HF

Although they're less common, many other heart conditions can also lead to HF, including

  • Cardiomyopathy (inflammation of the heart muscle)
  • Diseases of the heart valves
  • Arrhythmia (abnormal heartbeat)
  • Congenital heart disease or heart defects (heart problems you are born with)

Certain other conditions can also damage the heart and lead to HF, including

  • Cancer treatments (radiation and some chemotherapy drugs)
  • Thyroid gland disorders
  • Alcohol abuse
  • HIV/AIDS
  • Use of cocaine or other illegal drugs

+What are the most common conditions that lead to HF?

The most common cause of HF in African Americans is uncontrolled hypertension (high blood pressure). In white patients, the most common cause is coronary artery disease.

+How can I reduce my risk of HF?

Reducing your risk for HF begins with regular checkups. These checkups can tell you if you have any common but treatable conditions that may lead to HF, such as high blood pressure, diabetes, or high cholesterol. If you do, following your doctor’s directions on taking medicine and managing your condition can lower your risk for HF. Other heart-healthy habits can also help, including eating a low-salt, low-fat diet, getting regular exercise, managing your stress, and cutting back on or eliminating smoking and alcohol.

+What other conditions can lead to HF?

Other conditions that can lead to HF include heart valves that don’t work like they should, abnormal heartbeat (arrhythmia), heart defects you were born with, thyroid disorders, some cancer treatments, and more.

+What are the signs and symptoms of HF?

The most common signs and symptoms of HF are shortness of breath, feeling tired after even a little physical activity, and swelling in the feet, legs, and stomach.

+How is HF diagnosed?

Most cases of HF are not diagnosed until symptoms appear. Your doctor can tell you if you have HF after you have a thorough checkup and discussion about symptoms, as well as having your heart function tested. The most useful test is called an echocardiogram, which creates a moving image of your heart at work. Other tests may include an electrocardiogram, x-rays and other imaging studies, an exercise stress test, and various blood tests.

Risk of HF in African Americans

+ Are African Americans really at greater risk for HF than other Americans?

Yes. African Americans are 50% more likely to develop HF compared with other ethnic groups in the United States. In addition, African Americans tend to develop HF earlier in life and tend to have symptoms that are more severe and worsen more quickly. This means that African Americans are hospitalized more often and have higher death rates from HF.

+Why are African Americans at greater risk for HF?

There are 2 well-known reasons for African Americans having a greater risk of HF. One is that African Americans are more likely to have high blood pressure. The other is a higher rate of diabetes. Additional potential risk factors for the African American community may include lower access to and use of healthcare services, more exposure to environmental pollutants, obesity, and not getting enough exercise. Biology may also play a role. Studies have shown that African Americans are more likely to develop HF as a result of uncontrolled high blood pressure, while HF in white patients is more often caused by coronary artery disease. This difference could be because African Americans have lower levels of nitric oxide in their blood. Nitric oxide helps blood vessels relax and widen, making blood flow easier. Without it, blood vessels narrow and harden, causing high blood pressure and other heart problems.

Treatment for HF

+Can HF be cured?

HF cannot be completely cured. In some cases, HF may get better if the cause (such as a blocked artery or bad heart valve) can be treated with surgery. In general, early diagnosis, lifestyle changes (improved diet, exercise, quitting smoking, and reducing alcohol intake), and treatment with medicine are the best ways to help manage symptoms and slow or stop HF progression. However, the medicines must be taken for the rest of your life.

+What are the steps for treating HF?

Regular doctor visits are recommended. Your doctor will monitor your symptoms and prescribe medicines to treat HF symptoms and underlying causes. Sometimes an underlying cause of HF—such as blocked arteries or bad heart valves—can be corrected with surgery or other procedures. Lifestyle changes may also help. These would include eating more healthy foods, being more active, and quitting smoking.

+How can I get the best results from the treatment plan my doctor recommends?

Follow your doctor's advice as closely as possible, ask questions as needed, and share information about how you're dealing with the recommended treatment plan. Download our guide on talking with your doctor for more information.

+How can I make the most of my doctor visits?

Bring a list of questions you need answered and take notes to record answers and any instructions your doctor gives. Be sure to tell your doctor about any other medications, vitamins, or supplements you take. Also use these visits to share any frustrations about treatment with your doctor or inquire about help that's available for making lifestyle changes. For other tips on making the most of your doctor appointments, download our guide on talking with your doctor.

+What medications are commonly prescribed for HF?

HF patients are usually treated with a combination of medicines. ACE inhibitors and ARBs help lower blood pressure and expand blood vessels for easier blood flow. Beta blockers, which lower blood pressure and slow the beating of the heart, are also recommended. Diuretics (“water pills”) can be used to reduce fluid buildup. Digoxin helps the heart beat stronger so it pumps more blood. Your doctor may decide to give you other medicines as well.

+Are there other treatments for HF?

Yes. BiDil® (isosorbide dinitrate/hydralazine HCI) is just one medicine used to treat HF. Approved by the US Food and Drug Administration to treat self-identified African American patients with HF, BiDil is used in combination with other standard HF medicines. The African American Heart Failure Trial (A-HeFT) showed that taking BiDil with other heart failure medicines helped African American patients with HF live longer, reduced their rate of first hospitalization, and helped them have a better quality of life than using standard HF medicine alone.1

Please see the full Prescribing Information for BiDil.

+Who shouldn't take BiDil?

Anyone who is allergic to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Sorbitrate® or Isordil®) should not take BiDil. BiDil has a nitrate component, so you need to let your doctor know. There is little experience in patients with HF who experience significant symptoms while at rest.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs, like Viagra®/Revatio™ (sildenafil), Levitra® (vardenafil), or Cialis® (tadalafil). Mixing these with BiDil may cause a sudden drop in blood pressure, fainting, chest pain, or heart attack.

Also, tell your doctor if you are taking any medication to decrease blood pressure because, when taken with BiDil, your blood pressure may become too low.

+What are the most common side effects of BiDil?

Headaches often occur with BiDil treatment, especially when you first start treatment. These may become less frequent and less intense over time.

You may also feel lightheaded or dizzy, especially when standing after lying or sitting down. Drinking alcohol when taking BiDil could also cause you to feel lightheaded.

+What else do I need to know about BiDil?

Drinking fewer fluids than your doctor recommends or losing fluid due to diarrhea, sweating, or vomiting may cause low blood pressure, lightheadedness, or fainting. If fainting occurs, stop taking BiDil and contact your doctor immediately.

Lightheadedness may occur when standing, especially after sitting or lying down.

If you experience achy or swollen joints, unexplained fever for more than a few days, skin rashes, chest pain, prolonged weakness or fatigue (even after a good night's sleep), or any other unexplained signs or symptoms, make sure to tell your doctor as they may be signs of a serious medical condition.

You may also experience
  • Rapid heartbeat that could lead to chest pain or aggravate chest pain
  • Numbness or tingling in the hands or feet
If you have any of these symptoms, talk with your doctor.

+Will I be able to stop taking medicine for HF at some point?

No. HF medicines are generally needed for life, even if you begin to feel better. Medicine types and dosages may be changed, however. So regular doctor visits for tests and symptom monitoring are vitally important.

+What if the cost of my medication is a concern?

Always talk to your doctor as soon as possible if cost is an issue. BiDil has a savings card that may help lower your co-pay cost. Many drug companies also offer patient assistance programs that help people with limited income and no insurance coverage to afford their medicines. Your doctor can help you apply for these cost-savings programs. If your doctor prescribes BiDil for you, you may qualify for an assistance program offered by the manufacturer. The Arbor Patient Assistance Program offers free medicine to patients who are eligible.

+What if medication and other treatments don't keep my HF from progressing?

People with severe HF sometimes require hospitalization for special treatments and close monitoring. When medicine and lifestyle changes alone no longer work, HF patients may require a mechanical heart pump device or heart transplant.

BiDil and the African American Heart Failure Trial (A-HeFT)1

+What is BiDil?

BiDil is a fixed-dose combination medicine consisting of isosorbide dinitrate and hydralazine hydrochloride. It is approved by the FDA for the treatment of heart failure in self-identified African American patients when added to standard HF medicines. You can find out more about how BiDil works here.

+What was the clinical trial that studied BiDil?

The African American Heart Failure Trial (A-HeFT) studied 1,050 self-identified African American patients with HF. It is the largest number of African American patients ever studied in a major HF trial. A-HeFT was a randomized, placebo-controlled, double-blind trial with patients recruited at 161 centers in the United States.

Patients were "randomized," which means they were randomly put into one of 2 groups—532 patients received a placebo (a sugar pill) plus other standard HF medicines. The other 518 patients received BiDil plus other standard HF medicines.

This clinical trial design is the best way to test the effects of medicines. The trial was "placebo controlled." That means that one group took a placebo and one group took BiDil. "Double-blind" means that neither the patients nor the researchers knew who received placebo and who received BiDil. This helps to prevent any unconscious or unintentional bias.

A-HeFT was started on May 29, 2001, and the study was stopped early in July 2004 due to a significant survival benefit seen with BiDil as compared to standard therapy alone.

+What were the "standard HF medicines" used in A-HeFT?

The medicines most commonly used in A-HeFT were diuretics, or “water pills” (94% of patients), ACE inhibitors or ARBs (93% of patients), and beta blockers (87% of patients). All of the patients in A-HeFT (in both groups) were well treated with existing standard HF medicines before receiving either BiDil or a placebo.

+What were the results?

A-HeFT showed that BiDil plus standard HF medicines delivered
  • 43% survival benefit
  • 39% reduction in the rate of first hospitalization for HF
  • Significant improvement in quality of life measures, as rated by the Minnesota Living with Heart Failure Questionnaire

+Why was A-HeFT stopped early?

For patient safety, all clinical trials have an independent group of doctors called the "Data Safety and Monitoring Board" (DSMB). The DSMB is independent of the company and the doctors running the clinical trial.

The job of the DSMB is to review the progress of the clinical trial at regular intervals. They check to ensure that the drug therapy is safe and is not causing any harm to patients. They also monitor the results to see if the study drug shows better-than-expected benefits or if it is failing to show any difference from the placebo or other treatment used for comparison.

In July 2004, all the members of the DSMB and Steering Committee voted to stop A-HeFT early due to a significant survival benefit seen with BiDil plus standard therapy as compared with standard therapy alone.

+How important is BiDil for the treatment of HF in African Americans?

The American Heart Association (AHA) recognized BiDil as one of the top 10 advances in 2004.2

+Are there generic substitutes for BiDil?

No. The FDA has said that there is no therapeutically bioequivalent substitute for BiDil.

+What about claims that BiDil is a 'race drug'?

Only African American patients were studied in A-HeFT, so the FDA approval for BiDil is for "self-identified African American patients with heart failure" only. There is not enough clinical trial data to draw any conclusions about the effects of BiDil in other populations.

Two FDA doctors who participated in the approval of BiDil wrote an article in the clinical journal Annals of Internal Medicine in January 2007 entitled, "BiDil for Heart Failure in Black Patients: The U.S. Food and Drug Administration Perspective." In this article, they explain the FDA's decision to approve BiDil as follows3 :

"The FDA approval of a fixed combination of hydralazine hydrochloride-isosorbide dinitrate to treat heart failure in self-identified African American patients was a scientifically reasonable, data-based decision, one that provided a major benefit in a group that is particularly burdened by congestive heart failure. The evidence of benefit in African American patients is very strong, and the evidence that white patients have less, if any, benefit, is also strong. We hope that further research elucidates the genetic or other factors that predict the usefulness of hydralazine hydrochloride–isosorbide dinitrate. Until then, we are pleased that one defined group has access to a dramatically life-prolonging therapy."

"Not understanding the reasons for the difference in treatment effect by race did not justify withholding the treatment from those who could benefit from it."

"Using race or ethnicity to find out why people have different genomics and other physiologic characteristics isn’t a perfect science. But it can be a useful way to help understand racial differences until the pathophysiologic reasons are more clear."

Other ways to manage HF

+Can I do anything else to keep myself healthy and prevent HF from worsening?

Yes. Taking an active role in your care can help you get the best treatment possible. Make the most of your doctor visits by asking questions and looking for ways that will help you stick with your treatment plan. In addition, taking steps toward heart-healthy changes in your daily life will go a long way toward helping you feel better and keeping you as healthy as possible in the long run.

+How can I create an open line of communication with my doctor?

Good doctors welcome patients who want to take an active role during their office visits. It helps them make the best treatment choices for a particular patient's HF. Bringing a list of questions that are important to you to each doctor visit will help get this kind of back-and-forth discussion rolling. You should also share any frustrations or problems you have with following your treatment plan. Your doctor will pay close attention and offer ways to help you.

+How can I stay informed about my condition and treatment options?

In addition to asking your doctor questions you need answers to, it helps to do some homework on your own. The Internet can be a wonderful resource for learning more about your condition, staying on top of new research, and reading about new treatment options. Choose websites supported by established and reputable organizations, content that is updated regularly, and privacy policies that protect any information you provide. Never make changes based on Internet information, however, without asking your doctor first.

+What heart-healthy changes should I consider making?

Your doctor will likely recommend a diet low in salt and cholesterol, more physical activity to build strength and fitness, losing weight if needed, and quitting smoking and limiting alcohol intake.

+How can I be successful at creating and keeping healthier habits?

Don't expect to make drastic changes overnight without setting yourself up for frustration and failure. Take it one step at a time, but commit to reaching your goal. Always ask your doctor or nurse for resources that can help you make these changes easier. Most people need some outside guidance and support to develop new health habits that last.

IMPORTANT SAFETY INFORMATION

Tell your doctor about any allergies you have, especially if you're sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil®). BiDil has a nitrate component, so you need to let your doctor know.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio(sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil).

Information for Patients about BiDil® (isosorbide dinitrate/hydralazine HCl)

BiDil is approved for use with other heart medicines to treat heart failure in black patients to improve survival, improve heart failure symptoms, and help patients stay out of the hospital longer. There is little experience in patients with heart failure who experience significant symptoms while at rest. Most patients in the clinical study of BiDil also received other heart failure medicines.

IMPORTANT SAFETY INFORMATION

Tell your doctor about any allergies you have, especially if you're sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil®). BiDil has a nitrate component, so you need to let your doctor know.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio(sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil).

WARNINGS AND PRECAUTIONS

Also tell your doctor if you are taking any medication to decrease blood pressure because when taken with BiDil, blood pressure may become too low.

It is possible you'll get headaches, especially at first, but they often lessen over time. Keep your doctor posted on your headache progress; he or she may want to adjust your dosage.

If you experience dizziness, call your doctor. Please make sure to tell your doctor about any of the signs or symptoms mentioned below or about any unusual events that worry you.

Drinking less fluids than your doctor recommends or losing fluid due to diarrhea, sweating, or vomiting may cause low blood pressure, lightheadedness, or fainting. If fainting occurs, stop taking BiDil and contact your doctor immediately.

Lightheadedness may occur when standing, especially after sitting or lying down.

If you experience any achy and/or swollen joints, unexplained fever for more than a few days, skin rashes, chest pain, prolonged weakness or fatigue (even after a good night's sleep), or any other unexplained signs or symptoms, make sure to tell your doctor as they may be signs of a serious medical condition.

You may also experience rapid heartbeat that could lead to chest pain or aggravate chest pain, or numbness or tingling in the hands or feet.

COMMON SIDE EFFECTS

Headache and dizziness were the most frequent side effects experienced in studies with BiDil.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here to see full Prescribing Information for BiDil. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Ask your doctor if BiDil may be right for you.

References 1. Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004;351(20):2049-2057. 2. Jeffrey S. AHA top 10 for 2004 includes implantable artificial heart, rimonabant. Heartwire from Medscape. December 30, 2004. www.medscape.com/viewarticle/787223. 3. Temple R, Stockbridge NL. BiDil for heart failure in black patients: the U.S. Food and Drug Administration perspective. Ann Intern Med. 2007:146(1):57-62.