|
Atenolol vs. Losartan Clinical Trial
|
A clinical trial to compare the effects of the drugs atenolol and losartan on people with Marfan syndrome began in 2007. The clinical trial is based on research that showed a drug known as losartan prevented aortic enlargement and other Marfan features in mice that have Marfan syndrome. Q & A Q & A WHAT IS THE ATENOLOL VS. LOSARTAN CLINICAL TRIAL?
A clinical trial to compare the effects of the drugs atenolol and losartan on people with Marfan syndrome began in 2007. The clinical trial is based on research that showed a drug known as losartan prevented aortic enlargement and other Marfan features in mice that have Marfan syndrome. WHO IS IN CHARGE OF THE CLINICAL TRIAL?
The trial is funded by the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH), and conducted by the Pediatric Heart Network (PHN). The National Marfan Foundation (NMF) is also helping to support the trial. WHAT IS THE TRIAL STUDYING?
The clinical trial is studying two drugs, atenolol and losartan, to see which one is better at slowing aortic growth. It also looks for and compares any side effects that can happen when a person takes either drug. Once you are accepted into the clinical trial, you may be able to be in other smaller studies (ancillary trials). Your study site coordinator will tell you about the ancillary trials and what they are studying. The ancillary trials are offered at some but not at all sites. WHAT IS ATENOLOL?
Atenolol is a medication often used to treat high blood pressure. It is in a class of drugs called beta blockers. It is used to treat people with Marfan syndrome because lowering blood pressure may slow down how fast the aorta grows. In this way atenolol may delay, but rarely prevent, the need for aortic surgery in some people. WHAT IS LOSARTAN?
Losartan is another medication used to treat high blood pressure. It is in a class of drugs called angiotension receptor blockers (ARB’s). It may help manage Marfan syndrome in a way different from lowering blood pressure. The clinical trial is the first time losartan is being studied in people with Marfan syndrome. The trial will help find out if losartan is a safe and effective method. WHO CAN BE IN THE TRIAL? (What are the criteria for trial participation?)
To be in the clinical trial you must: - Be between the ages of six months and 25 years at the time you begin the trial.
- Have a diagnosis of Marfan syndrome.
- Not be pregnant.
- Not have had any aortic surgery.
- Not have serious side effects from either atenolol or losartan.
- Not need to take atenolol or another beta blocker to treat a medical problem other than your dilated aorta.
- Be willing and able to travel 5 times over 3 years to the study site for all study echocardiograms and examinations.
HOW MANY TIMES WILL I HAVE TO TRAVEL TO THE CLINICAL TRIAL SITE?
You will travel to the trial site a total of 5 times over 3 years, twice the first year and once each subsequent year. You will go for an initial screening visit. Then you will go for a 6 month, 12 month, 24 month and 36 month follow up visit. WHAT SHOULD I EXPECT TO TAKE PLACE DURING THE 5 VISITS TO THE TRIAL SITE?
At each visit you will be asked to complete a questionnaire to determine if you/your child is experiencing any side effects from the medication. Measurements will be taken at each visit. Measurements will include weight, height, arm length and leg length. Blood tests will be done at some but not at all visits. An echocardiogram will be done at each visit. An echocardiogram is a painless test using sound waves to take a picture of your heart. A 24-hour electrocardiogram will be done at each visit. This requires you wearing a holter monitor for 24 hours. The monitor records the rhythm of your heart. The monitor is the size of a pager. If you don’t live near the trial site, the monitor can be sent via Federal Express to you and returned the same way. The trial site will ensure you know how to use the monitor. WHAT IF I WAS SCREENED FOR THE CLINICAL TRIAL AND I DID NOT MEET THE Z-SCORE REQUIREMENTS? CAN I BE SCREENED AGAIN?
Yes. If you have already been screened or plan to be screened and you don’t meet the z-score requirement, you can be screened again in the future. Over time the aorta may enlarge further making you eligible for the clinical trial. DOES EVERYONE IN THE TRIAL TAKE EITHER ATENOLOL OR LOSARTAN?
Everyone in the trial will receive either atenolol or losartan. This means everyone will receive a medication. There is no placebo (sugar pill) group. Your medication is chosen by chance. You and your doctor will not know which medication you are taking. CAN I STILL BE IN THE TRIAL IF I ALREADY TAKE ATENOLOL OR LOSARTAN?
For most people the answer is, yes. You will be slowly taken off the medication you now take and then put on either atenolol or losartan. It is important to understand, however, you cannot be in the trial if you need to take atenolol or another beta blocker to treat a medical problem other than your dilated aorta. DO I HAVE TO STOP SEEING MY CURRENT DOCTORS IN ORDER TO BE IN THE CLINICAL TRIAL?
No. You can be in the clinical trial and continue to see your current doctors. In fact, it is important that trial doctors talk with and work with your current doctors. I WANT TO BE IN THE TRIAL. WHAT SHOULD I DO?
Contact the coordinator at the site of your choice. List of enrollment sites. The coordinator will talk to you about the trial, answer your questions and help decide if you are eligible to be in the trial. I WANT TO BE IN THE TRIAL BUT CANNOT AFFORD TO TRAVEL TO A STUDY SITE. WHAT SHOULD I DO?
Talk to the coordinator at the study site about your need for financial help. The coordinator will first need to decide if you are eligible for the trial. Then contact the NMF at Information Resource Center at 1-800-8-MARFAN ext. 26 (1-800-862-7326 EXT. 26) to request assistance with the travel. I WANT TO BE IN THE TRIAL BUT I HAVE NO INSURANCE OR MY INSURANCE WILL NOT PAY FOR OUT-OF-NETWORK ECHOCARDIOGRAMS. WHAT SHOULD I DO?
If a patient does not have insurance or insurance will not cover the yearly echocardiogram fee because echocardiograms are out-of-network, the study site can get reimbursed for the echocardiogram fees from the NMF by filling out the required forms. This assistance has to be requested by the study site itself. The NMF is providing these funds to help ensure that patients interested in participating in the trial get the opportunity to do so, even if they have no insurance or their insurance will not cover the costs of out-of-network echocardiograms. Please discuss this with your study site coordinator and call the NMF Information Resource Center at 1-800-8-MARFAN x 26 (1-800-862-7326 EXT. 26) if questions still exist. ARE THERE ADDITIONAL STUDIES ASSOCIATED WITH THE CLINICAL TRIAL THAT I CAN PARTICIPATE IN?
Yes. There are two additional studies that you can participate in. The first study is a genetic study. This study will look for connections between a person’s response to the drug they are taking as part of the core clinical trial and the mutations they have on genes related to Marfan syndrome, such as fibrillin-1 and others. By studying genetic factors and the differences in response to these drugs, the researchers hope to learn who will benefit most from taking these drugs and ultimately learn how to create more personalized drug treatment plans. In addition, the genetic knowledge gained from this study might help explain the variable expression seen in Marfan syndrome (why some people are more severely affected than others). Participation requires giving one extra blood sample during a visit to the study site. All information obtained from the study will be strictly confidential. The second additional study will be used to determine if losartan can influence muscle and bone aspects of Marfan syndrome. Through the use of physical activities, magnetic resonance imaging (MRI) and DEXA scans taken two times during the trial, this study will look at the effects of losartan and atenolol on strength and endurance and on bone and muscle mass. An MRI is a special imaging technique that can make images of inside the body and a DEXA scan is a special x-ray study commonly used to measure bone density to evaluate for osteoporosis (thin bones). In this study, the scans will measure how much fat and muscle is in the whole body as well as bone density. If losartan or atenolol has an effect on muscle mass or bone density, doctor may be better able to manage bone and joint problems in people with Marfan syndrome. You must be eight years or older to participate in this ancillary study. Not all trial sites are participating in this study. I AM NOT ELIGIBLE FOR THE CLINICAL TRIAL. BECAUSE IT IS AN APPROVED MEDICATION, CAN MY DOCTOR PRESCRIBE LOSARTAN FOR BLOOD PRESSURE CONTROL?
The National Marfan Foundation does not recommend switching from a beta blocker to losartan as a way to manage Marfan syndrome until the trial is completed. This is because we do not know whether losartan is clearly better than atenolol for taking care of people with Marfan syndrome. Also, we do not know if people with Marfan syndrome will have unwanted side effects when they take losartan.
Click these links for more clinical trial information:
An Introduction to Clinical Trials
Losartan Q & A
Johns Hopkins Press release Science Journal Publication (04/06)
Connective Issues Article "Why the Marfan Community Needs the Losartan vs. Atenolol Clinical Trial"
Connective Issues Article "Iowa Family: 'We Truly Need This Study, So We Can Know'
NPR Story:"Old Drug Offers New Hope for Marfan Syndrome"
NIH Launches New Web Site for Parents on Medical Research Studies for Children
|
