Next time you open your medicine cabinet or fill a prescription, think about this: New drugs go through an average of 12 years of rigorous testing before they are deemed safe and effective for people to use.
Research is done through clinical trials, which are essential for improving health and medical care.
Clinical trials are proving ground for new or better:
- Procedures or techniques
- Ways to prevent and diagnose disease
Without these studies, and the people who volunteer to take part in them, many common medicines including aspirin, statins to lower cholesterol, beta blockers for high blood pressure and the newer diabetes medicines would not be available today. Nor would we have developed such a deep understanding of diseases such as heart disease and stroke, and how best to treat and prevent them.
The Food and Drug Administration (FDA) requires rigorous scientific studies to prove that a treatment or device is both safe and effective before allowing it to be available to patients. Altogether, more than a hundred FDA-approved drugs and devices are available to treat or stave off cardiovascular disease, and they work in different ways.
What Are Clinical Trials
Clinical trials are carefully planned research studies that assess new drugs, devices, procedures, biologics (for example, vaccines or targeted therapies), diagnostic approaches/tools.
These studies also test interventions that might help prevent another heart attack or slow the progression of diseases (for example, cardiac rehabilitation or team-based care, etc.).
Research studies look at specific drugs or treatments to determine:
- If they are safe (and to identify what, if any, side effects might occur)
- If they work
- How they compare with current treatments (called usual or standard care)
- Optimal doses (amounts) and frequency of treatments
Cardiovascular studies help answer scientific questions and find new ways to:
- Detect and diagnose
- Manage symptoms of heart and vascular diseases
Often during research, the best standard treatment or procedure is compared with the best standard treatment + new drug or intervention.
Research studies also can be designed to look at large populations of people (called observational studies) and to identify important trends in heart disease over time.
Researchers also plan trials to evaluate how certain lifestyle habits such as diet or exercise influence outcomes. For instance, the DASH diet plan was shown in a clinical trial to lower blood pressure, especially among Black patients.
How Trials Work
Each clinical trial follows a specified protocol that spells out how the trial will be conducted. Think of the protocol as the rules that must be followed to ensure the results are consistent and reliable.
Among other details, the study protocol clearly defines:
- The reason for doing the trial: What question needs to be answered.
- How many people are needed: The number of people required to give the trial enough power so that the findings apply to those who would use the treatment being studied.
- Who can and cannot take part in the trial: These are called eligibility criteria.
- The treatment plan/intervention: This describes the medication or device under study, including when, how and at what dose it will be given.
- How patients will be assigned to each study group: For randomized trials, participants in the treatment and control groups are similar at the start of the study and most, if not all, other factors are kept the same; this way, researchers have good reason to believe that if the outcomes differ among study groups it is because of the treatment.
- Who is in the know: Trials are often double-blinded, meaning that neither the participant nor the researcher knows which therapy is being given to whom.
- What tests and follow up will be done, how often and for how long
- What type of data or information will be collected and how often: For example, the protocol lists which measures will be tracked, such as blood pressure or cholesterol levels and/or whether someone has a cardiac event or goes to the hospital during the study period.
This plan is especially important when there are multiple sites and researchers involved. It helps ensure the research is done in the same way across each facility. Studies are bound by strict regulatory and ethical standards.
Questions to Ask
It’s important to talk with your health care team about how you are feeling and if your current treatment plan is working for you. A lot of research us underway, so taking part in a clinical trial may be or become an option for you in preventing or treating heart disease.
If you’re thinking about participating in a clinical trial, here are a few questions you might want to ask:
- Is a clinical trial the right option for me given my medical history and prognosis?
- How do I find a clinical trial that might benefit me?
- How long will the study last?
- What are the risks?
- What does randomized mean?
- What are the costs?
What can you do to help protect your cardiovascular health? Here are some ways you can work together with your care team to stay healthy or manage your condition—or both!
Learn About Your Condition
This is an essential first step to a healthier heart—both now and in the future. The more you know about your condition and how to manage it, the better you will feel.
You may be bombarded with information and advice from your health care team, especially when you are first diagnosed or if your treatment needs to be changed for some reason. Don’t be sheepish about asking your health care provider to repeat or explain anything that is unclear to you.
You can also explore CardioSmart.org to learn more about health topics, the latest research, and questions to ask your care team.
Partner With Your Health Care Team
Playing an active role in your health care will help you to feel more in control. By being involved from the start, you and your health care team can work together to map out a treatment plan to best meet your specific goals.
If you have heart failure, for example, weighing yourself daily and tracking your weight will provide a valuable record for your health care team and alert you to call your doctor if you’ve gained weight too rapidly (more than 2 pounds overnight or 3 pounds in one week).
Keep Up With Your Health Visits
Keep all medical appointments and be prepared. Your doctor will want to see you on a regular basis to monitor your health. Even if you feel better or have other demands on your time (work, family, etc.), you need to make these visits a priority.
Follow your treatment plan. No matter what your condition or treatment, it’s important to follow your doctor’s advice. It’s the only way that you and your health care team will know if the treatment is working or if changes are needed.
Take Your Medications as Directed
Many people living with heart disease take medications to prevent problems and/or feel better. But in order for these medications to work, you must take them correctly.
Here are a few other tips to keep in mind:
- Take the time to understand why your doctor prescribed a specific medicine. You’ll feel better about taking the medication if you know why it is needed and how it can help.
- Ask your doctor about side effects and how best to manage them.
- Never stop, skip or change the amount (dose) of medication you take without talking with your doctor first.
- Keep a current list of all medications you take, including any over-the-counter medications, herbal remedies and dietary supplements. Share this list with your health care providers at each visit.
- Remember, too much medicine—or not enough—or taking certain medications or supplements together can be dangerous.
Lead a Healthier Life
Hearing that you have or are at risk for cardiovascular disease can be very worrying. Many people say it was the wake-up call they needed to make positive lifestyle changes.
- Be physically active. Talk with your health care provider about a regular exercise program that is appropriate for your condition and fitness level. Remember, activities like gardening, riding a bike or cleaning the house count as activity.
- Eat well. Make smart, heart-healthy food choices. That means eating a diet rich in fruits, vegetables and whole grains and cutting down on saturated, trans and other types of fats.
- Don’t smoke or drink alcohol to excess. Women should have no more than one-half drink per day; men should have no more than one drink per day.
- Maintain a healthy weight.
Know What Increases Your Chance of Heart Problems
Make sure that you and your health team are aware of your risk factors—those things that make it more likely for you to have heart disease, stroke or repeat cardiac events.
Make Time to Relax
Prolonged stress and anxiety can affect your body and your heart. Take care of yourself and try to lower stress levels by setting limits, getting a massage, signing up for a yoga class, meditating or engaging in other activities that help you to relax.
Managing a chronic (or ongoing) condition can take a lot out of you. There will be good and bad days. Joining a support group, talking openly with family and friends or keeping a journal can help you cope.
Don’t be afraid to seek professional help if needed. Consider bringing a family member or trusted friend to your doctor visits, especially if you have a complicated condition.
In order to maximize the interaction between you and your cardiologist at your next visit, it is best to come prepared. There are materials you should bring with you and ways you should prepare for your appointment. Here are some tips for a more meaningful visit:
- Always bring a list of your current medications. A sheet of paper with all your current medications written out or typed out (including name, dose, and frequency of use) is an invaluable resource for your cardiologist. A list of any medication allergies is also helpful. Having these pieces of information written out helps ensure accuracy in your medical record.
- Carry a list of your health care providers including name, address, telephone number, and condition being followed. This will help ensure that communication between your cardiologist and all of your other care providers is complete.
- Compile a list of your past health history. Important to include are any surgical procedures (with at least approximate dates), a list of any major prior or ongoing illnesses/health issues, and a list of any major tests, especially if performed within the last year. Knowing past health events can help the physician make a diagnosis or prescribe the best course of treatment.
- Compile a family health history of close blood relatives. This includes brothers, sisters, parents, grandparents, aunts, uncles, and children. From a cardiology perspective, what you are especially interested in finding out is whether any of your relatives have been diagnosed with heart disease, high blood pressure, high cholesterol, diabetes, or aneurysm. Knowing when any of your relatives passed away and cause of death is also important. A family history of health events can provide clues as to what illnesses/conditions you may be at risk for developing.
- If you have them, bring in copies of any recent lab results and any other test results from the past year, especially if the testing took place with a different health care provider. This will help avoid duplicating tests unnecessarily.
- Find out more about your condition before your appointment. Having a better understanding of your condition ahead of time will allow you to have a more meaningful discussion with your physician.
- Write down a list of the questions you have about your condition and bring it with you to the appointment. You might want to pick the top three or four concerns you would like to have addressed during your visit. Even though this might seem silly, it is easy to get sidetracked during a health visit. Write down ahead of time what pieces of information you want to leave with.
- Keep yourself organized. Putting all this data into a folder is a good idea so it’s easy to access during your visit.
- Don’t take anything for granted. Although information systems are getting better, and communication between systems is improving, you are still the most reliable repository of your health care record. Keep your copy accurate and up-to-date.
A cardiologist is a doctor with special training and skill in finding, treating and preventing diseases of the heart and blood vessels.
How are Cardiologists Trained?
Cardiologists receive extensive education, including four years of medical school and three years of training in general internal medicine. After this, a cardiologist spends three or more years in specialized training. That’s 10 or more years of training!
How does a Cardiologist Become Certified?
In order to become certified, doctors who have completed a minimum of ten years of clinical and educational preparation must pass a rigorous two-day exam given by the American Board of Internal Medicine. This exam tests not only their knowledge and judgment, but also their ability to provide superior care.
When Would You see a Cardiologist?
If your general medical doctor feels that you might have a significant heart or related condition, he or she will often call on a cardiologist for help. Symptoms such as shortness of breath, chest pains, or dizzy spells often require special testing.
Sometimes heart murmurs or ECG changes need the evaluation of a cardiologist.
Cardiologists help people with heart disease return to a full and useful life and also counsel patients about the risks and prevention of heart disease.
Also, cardiologists are involved in the treatment of heart attacks, heart failure, and serious heart rhythm disturbances.
Their skills and training are required whenever decisions are made about procedures such as cardiac catheterization, balloon angioplasty, or heart surgery.
What Does a Cardiologist Do?
Whether the cardiologist sees you in the office or in the hospital, he or she will review your medical history and perform a physical examination which may include checking your blood pressure, weight, heart, lungs, and blood vessels.
Some problems may be diagnosed by your symptoms and the doctor’s findings when you are examined. You may need additional tests such as an ECG, X-ray, or blood test.
Other problems will require more specialized testing. Your cardiologist may recommend lifestyle changes or medicine. Each patient’s case is unique.
If your general medical doctor feels that you might have a significant heart or related condition, he or she will often call on a cardiologist for help. A cardiologist is a doctor with special training and skill in finding, treating and preventing diseases of the heart and blood vessels.
Symptoms like shortness of breath, chest pains, or dizzy spells often require special testing. Sometimes heart murmurs or ECG changes need the evaluation of a cardiologist.
Cardiologists help people with heart disease return to a full and useful life and also counsel patients about the risks and prevention of heart disease. Cardiologists are involved in the treatment of heart attacks, heart failure, and serious heart rhythm disturbances. Their skills and training are required whenever decisions are made about procedures such as cardiac catheterization, balloon angioplasty, or heart surgery.
What is a Physician Assistant?
A Physician Assistant (PA) is a health care professional who is authorized by the state to practice medicine as part of a team with a physician or group of physicians. PAs deliver a broad range of medical and surgical services, including: conduct physical exams, obtain medical histories, diagnose and treat illnesses, order and interpret tests, counsel on preventive health care, assist in procedures and prescribe medications.
You may see a PA in the hospital admitting patients, performing hospital rounds, supervising stress testing, or assisting the cardiologists in the cardiac catheterization lab and electrophysiology lab. They are trained and certified in Advanced Cardiac Life Support and can respond to cardiac emergencies as they arise.
In the office setting PAs are trained to see both stable cardiac patients as well as the acutely ill. They perform pre-operative clearance exams for non-cardiac surgery. They can perform consolation evaluations on new cardiac patients. Cardiology PAs work as a team in collaboration with the cardiologist(s).
What is a Nurse Practitioner?
Nurse practitioners (NPs) are registered nurses who are prepared, through advanced education and clinical training, to provide a wide range of preventive and acute health care services to individuals of all ages. NPs complete graduate-level education preparation that leads to a master’s degree.
NPs take health histories and provide complete physical examinations; diagnose and treat many common acute and chronic problems (such as diabetes, high blood pressure, infections and injuries); interpret laboratory results and X-rays; prescribe and manage medications and other therapies; provide health teaching and supportive counseling with an emphasis on prevention of illness and health maintenance; and refer patients to other health professionals as needed.
What is a Registered Nurse?
Registered nurses (RNs) provide and coordinate patient care, educate patients and the public about various health conditions, and provide advice and emotional support to patients and their family members.
Registered nurses perform physical exams and health histories, counseling and education patients about their health. RNs may also administer medications, interpret patient information and make critical decisions about needed actions. Additionally, RNs coordinate care, in collaboration with a wide array of health care professionals and may direct and supervise care delivered by other health care personnel.
What is a Clinical Pharmacist?
Clinical pharmacists are the medication experts. You might not realize it, but they do much more than count tablets and pour liquids. They routinely provide medication recommendations to patients and health care professionals. Clinical pharmacist researchers generate, disseminate, and apply new knowledge that contributes to improved health and quality of life.
Clinical pharmacists are a primary source of advice regarding the safe, appropriate, and cost-effective use of medications. They often collaborate with physicians and other health care professionals. In some states, clinical pharmacists are given prescriptive authority under protocol with a medical provider (i.e., MD or DO), and their scope of practice is constantly evolving.
The use of medications has led to dramatic advances in the treatment and prevention of many cardiovascular diseases. It’s thanks to many of these medications – combined with heart-healthy lifestyle changes – that many people are living longer and feeling better.
But medications only work if you take them as directed. If you skip doses, elect not to take a prescribed medicine or take too much, it can be dangerous.
In fact, not taking medication as prescribed – medication non-adherence – is a leading reason for hospitalizations, more frequent doctor visits and medical costs. It can also interrupt timely care.
Think about it this way: Managing your medications is just as important to protect your heart health as getting enough exercise and eating a heart-healthy diet.
Getting the Most From Your Medications
In many cases, treatment for heart disease includes a balance of healthy lifestyle changes (diet, exercise and sufficient sleep), medications and, for some patients, devices and/or other surgical procedures.
To get the most from your medications:
- Learn about each medication and why it has been recommended. For example, ask questions to be certain you understand how it works, how and when to take it, common side effects and what to do if you skip a dose or run out of medicine.
- Remember medications work best when they are taken in the right dose, at the right time and in the right way. The benefits of doing so are:
- Better treatment of symptoms and other outcomes
- Fewer side effects or drug interactions
- A lower likelihood of unnecessary treatments and hospitalizations
Continue to take your medication—even if you feel well or don’t have signs of the disease.
- Guard against interactions, which may mean your medicine will not work as well and you may experience more severe side effects.
- Give all of your health care professionals—your doctors, nurses, dentist, and pharmacist—an updated list of all of the medications you take, including over-the-counter drugs and supplements
- Consider using one pharmacy so your pharmacist can review all of your medications and flag any issues
- Tell your health care professional about side effects or concerns. Sometimes side effects can subside over time; your doctor may be able to manage them by adjusting your medications if needed. Many heart disease symptoms are similar to side effects from certain medications. Your health care professional can help discern which is which.
When Problems are More Likely to Occur
Medication-related problems can happen when and if you:
- Take multiple medications
- Don’t fill a new prescription or refill an existing prescription
- Take medications at the wrong time
- Skip or stop your medications without talking with your health care professional
- Take extra medication or doses
- Take medications that may interact with other drugs, alcohol, even certain beverages or foods
- Don’t report concerns or side effects from medications
- Use medications prescribed for someone else
- Have concerns about the cost of your medications—talk openly about cost; your health care team may be able to point you to assistance programs or recommend lower-cost alternatives
Tips to Help You Stay on Track
Here are some things you can do, especially if you take multiple medications, to help take your medications the right way.
- Get organized
- Use a weekly pill box; some also allow you to sort your pills daily by the time of day
- Keep a personal medication chart/schedule and mark each medication as you take it
- Talk with your doctor about home delivery pharmacies that pre-pour medications and put them in blister packaging for you
- Work your medications into your daily routine
- One of the best ways to remember to take your medications is to take them at set times during your normal routine. For example after breakfast or before brushing your teeth at night.
- Set a reminder or reminders
- Place reminder notes where you can see them
- Add it to your calendar or set a backup alarm on your smartphone or clock
- Keep a written record of all your medications in a safe place
- Use follow-up appointments as a chance to review your medications
- Medication regimens often need to be or can be adjusted, so be ready to talk about how you are feeling and any issues with your medication
- Ask about ways to lower costs if it’s a concern
- Get to know your pharmacist
- Your pharmacist is a wealth of information and can answer questions about side effects, interactions, how to take and store your medications and much more.
- Some pharmacies or prescription drug programs offer Medication Therapy Management (MTM) programs to review and track medications for certain people.
- Your pharmacist may be able to work with you and your health care team to find ways to reduce the number of pills you take or address any other challenges you have.
- Plan ahead for travel
- Let your doctor know if you need an extra supply of medications
- Bring a list of all of your medications and contact information for your pharmacy and care professionals; you may want to keep your medications in the original prescription bottle with your name on it
- Remember, it’s OK to take medication
- Some people don’t like the idea of taking medications, but heart disease is serious. Always share any concerns with your health care team.
- Enlist help
- Ask a trusted family member or friend to help you stay on top of your medications, order refills, report problems, etc.; there may be community services if and when they are needed
Be honest with your health care professionals if you are having trouble adhering to your medication regimen. Your doctor may be able to simplify your medication schedule if you take several each day.
Questions to Ask
Talk openly with your health care team about your medications—if you are having trouble taking them, if cost is an issue and anything else that might be getting in the way.
Here are some questions you might want to ask:
- Does this medication(s) interact with others I take? Are there foods or other medications I should avoid?
- Is there a way to make my medication regimen easier?
- Can you walk me through what condition each medication is intended to treat?
- What is this medication(s), why is it needed, and how does it work in the body?
- Why was this particular medication selected?
- What is the dosage schedule and related instruction to how to take the medication(s)?
- How long will I be taking this medication?
- How will we know if it’s working?
- How should the drug be stored?
- What do I do if I miss or delay a dose?
- What major and common adverse effects should I be concerned about?
- What are the brand and generic name(s) for the drug?
- Are there medications I don’t need anymore? How do I properly dispose of unused medications?
- How can I pay for my medications? Are there ways to reduce costs?
It is nearly impossible to listen to the evening news, scan the Internet or pick up a newspaper without hearing about the latest medical study. Even though these studies can make big headlines, most of us are left wondering what, if anything, it means to us or a loved one.
It’s important to know that clinical studies are rarely definitive. One study is just that. If anything, each study raises new questions and suggests future areas of investigation. Research may support earlier findings or have vastly different results, so the chapter is never closed.
That’s why, even if a treatment is found to be very effective, most authors still call for more research to better understand the intervention—who might benefit, if there are side effects, how it can be applied in practice and more.
Making Sense of Medical Research
Not all studies are well designed, and results can be taken out of context. But asking a few key questions can help you get useful information about the study. For example:
• Who paid for the study? Clinical research might be funded by government agencies like the National Heart, Lung, and Blood Institute; academic centers and foundations; or pharmaceutical or medical device companies. Conflicts of Interest or Disclosures by the investigators should be included in the article.
• How was the study done? There are lots of ways that researchers can test new medications or devices, procedures or behavior changes that may help people stay healthy. Randomized controlled double-blinded trials are considered the gold standard when it comes to study designs. This means that patients are randomly assigned to receive the new therapy or standard care or placebo and neither the patients nor the doctors know whether they are receiving the therapy. This helps eliminate potential for bias. Review articles and meta-analyses are also helpful in pulling together data from multiple studies and assessing the current state of knowledge about a particular treatment approach.
• Where was the article published? Not all scientific journals are the same. Articles that appear in “peer reviewed” journals have been strictly vetted by experts with no connection to the research. Examples of reputable journals include the Journal of the American Medical Association (JAMA), New England Journal of Medicine (NEJM), Journal of the American College of Cardiology (JACC) and Circulation.
• How many participants were included? The study should ideally include enough participants so that the findings can predict how the treatment will work in similar groups in the general population.
• Are the people in the study like you? Find out who took part to see if it even applies to you. For example, findings from studies that only include adult men may not apply to women. Early medical research is typically done in a laboratory using animals or cells, so don’t assume the research was performed in humans.
• How long did the study last? Researchers should follow patients long enough to be sure that the treatment really works. For example, to find out whether a certain diet lowers a person’s risk of heart attack would require years, even decades, of monitoring. Also, the longer a treatment is studied, the more information can be collected about side effects.
• Are the findings statistically significant? This means that there was a clear difference in treatment outcomes of those patients receiving the treatment in question and the likelihood this difference is due to chance is very small.
Doing Your Own Research
If you are like most Americans, you’ve probably searched the Internet to learn more about a news report, symptoms or a specific treatment. You can find a wealth of health-related information and resources 24-7.
Plus, the more you know about your condition and potential treatments, the more informed you will be when making decisions about how to treat or prevent problems.
But you need to be careful. Anyone can post information online, so some websites may contain false or misleading information. Be sure to limit your search to websites you know you can trust.
Assessing Online Information
Here are some tips:
• Stick with credible websites. Government health agencies and reputable medical organizations such as the American College of Cardiology are good sources. CardioSmart provides consumers with credible information and summaries of clinical studies about cardiovascular health and treatments. This information is reviewed by expert cardiologists.
• Is it fact or opinion? Information should be based on facts and credible medical research, not opinion.
• Has it been reviewed by a doctor or other medical expert?
• If it sounds too good to be true, it probably is. Be wary of websites or news reports that make dramatic health claims.
• Double-check what you’ve read. Compare the information you find in your Internet search with other reliable sources, such as a medical textbook and, most important, advice from your health care team.
• Ask your health care provider to help interpret the information. Just because a specific therapy worked under certain (study) conditions doesn’t mean it is the right treatment for you.
Questions to Ask
If you need help understanding medical news, the best thing to do is ask your health care provider. Your doctor knows your personal medical history and can tell you whether a particular study means anything for you. Keep in mind, he or she is likely to be cautious about new research to see whether it holds true in everyday practice.
You might want to ask:
• Did you hear about this study?
• What does it mean?
• Why did the researchers conduct this trial?
• Are the results applicable to me?
• Should this change anything we are currently doing?
• Where can I find more information?