Archive for the ‘Research’ Category

REACH for the goal!

August 12, 2010

Great news: The Adult Congenital Heart Association (ACHA) announced today that the Research Empowerment in Adult Congenital Heart Disease (REACH)  initiative would receive a one million dollar federal grant! The money will be used to activate CONGENERATE – The Congenital Evaluation, Reporting, and Tracking Endeavor. CONGENRATE is an Electronic Health Record (EHR) designed for Adult Congenital Heart Defect Survivors!

REACH is a joint project between the ACHA and the Alliance for Adult Research in Congenital Cardiology. The two groups are already working together on HEART-ACHD, a two-year study of why adult CHDers “fall through the cracks” and  get away from good Cardiological care. And we aren’t in this alone: CONGENERATE will be tested at Oregon Health Sciences University, Nationwide Children’s Hospital, Cincinnati Children’s Hospital Medical Center, Children’s Hospital Boston/Brigham and Women’s Hospital, and Children’s Hospital of Wisconsin.

Whenever I travel, I take a large folder with me that contains basic health information, my diagnosis, the names of my doctors (Including my team of Cardiologists in Atlanta and that I would rather they be the first doctors contacted) EKGs, and a diagram of my heart. It comes in handy – it was with me when I went to the Emergency Room in Houston, and I have a smaller version in my back pocket when I leave the house.

If CONGENERATE had began five years ago, I wouldn’t need my folder. I’d have an ID card or an access number that could have been entered into a computer and everything you need to know about me would appear on a computer screen! CONGENERATE should be ready to roll out sometime in 2012…. and if it is a success, perhaps the next project would be a similar application for Cardiac Kids!

ACHA’s vision for every CHDer is “a life unlimited by congenital heart disease.”  Projects like CONGENERATE are small baby steps in that direction.

The Fontan

August 10, 2010

In late 1987, my cardiologist recommended that I have the Fontan Procedure. Now I was doing pretty good, he said, but having the Fontan would bring me to as close to “normal” as I would ever get. I thought about it, and decided to have the operation – after I graduated college. I was one semester (three months) from graduation and thought that waiting long enough to officially finish school would be a good idea. So that is what I did, and my surgery was scheduled for May 1988.

If you are a regular Funky Heart! reader you know what happened. After heart surgery the heart develops a layer of scar tissue, and in my case there was a lot more than anyone had anticipated, and it had stuck to the back of my rib cage. When my ribs were cut open that scar tissue tore. I required 20 units of blood and nearly bled out on the operating room table. My surgeon, Dr. Albert Pacifico, managed to get the bleeding under control and then backed out – the risk of restarting the bleeding was just too great. And if it started again, this time Pacifico and his team may not have been able to stop it. (“I tried every trick I knew to stop the bleeding,” he said later. “And I even had to make up a few new tricks on the spot.”)

The difficult thing about the Fontan procedure for me is that while I am somewhat familiar with the history of the procedure, I can’t understand it or explain it. I read the books, I study diagrams, (The Illustrated Field Guide to Congenital Heart Disease and Repair has several good illustrations. They don’t seem to help me understand what I am looking at, though!) but I just can’t get into my head how it works. And apparently that is a common problem – the “standard” cardiac treatments don’t seem to work as well, or work differently. The heart itself doesn’t control cardiac output; that really depends on the lungs. Patients who live at higher altitudes can show marked improvement by relocating to a lower altitude – in some cases an operation that has never worked right can suddenly find a happy balance as the altitude decreases. But before we put all of our Fontan Survivors who live in the Rocky Mountains on a train bound for the coast, the altitude adjustment doesn’t always work.

The Fontan Procedure is named after Dr. Francios Fontan, a French surgeon, and was first described in 1971. (CLICK HERE to see the article that describes the Fontan in its original form.) Even the professionals seem to have difficulty understanding exactly why and how the Fontan works: A study of 476 Fontan operations were analyzed and a “Fontan Score” assigned to each individual procedure. Variables that could affect the Score included “surgical center, age, weight, fenestration, length of hospital stay at time of Fontan procedures, and post-Fontan surgeries or interventions.” When the Fontan Score was analyzed, only 18% of the variables could be explained; the rest (82%) of the factors were unknown. And any long-term study of the Fontan is going to be confusing, as the operation has been modified over the years. (Had my operation been successful I would have the second version of the Fontan, and it has been modified since then)

Fontan Survivors are also subject to arrhythmia, and people with stable Fontan circulations can and probably should have a mild to moderate exercise program. It is important that the patient is stable, so don’t just drive down to the gym one day and sign up for Jazzercise classes. Consult your Cardiologist first!

Another problem – a big problem – for Fontan Survivors is the possibility of developing Protein-Losing Enteropathy, or PLE. PLE is an unexplained loss of protein from the body, usually through the intestinal tract. PLE is not a side effect of Congenital Heart Disease, it only affects people who have had the Fontan. One large study done in 1996 found that ten years after having the Fontan, the cumulative chances of having PLE are 13.4%. A 2003 study concludes PLE could be triggered by an infection. This leads to the disturbing thought that maybe all single ventricle patients are predisposed to PLE, and the Fontan Procedure coupled with an infection is the “trigger” that sets it off.

Someone, somewhere, had the Fontan Procedure today… and despite the drawbacks of the operation, they will probably have a better life because of it. As a 2008 report concludes, “this imperfect circulation would still be the only surgical option for this difficult patient population.”

When the test doesn’t work

August 3, 2010

A recent clinical trial showed disappointing results: Enalapril, used to treat high blood pressure and heart failure, was being tested in infants born with a single ventricle heart. The basis of the trial was that since the drug works in adults, perhaps it will also work in children.

It didn’t work at all.  When the results were analyzed, the outcomes for Enalapril group and the Control group were  practically identical. The results of this randomized trial do not support the routine use of enalapril in this population, the researchers wrote.

Did the drug fail? Certainly, it did not produce the desired result. But the clinical trial shouldn’t be considered a failure – after all, now doctors know what not to do. They may not have any better answers, but now they know that prescribing Enalapril in these circumstances won’t work. And sometimes you have to learn what not to do before you figure out what you should do.

Cardiology is littered with the relics of operations, drugs, and procedures that were abandoned in favor of something better. As I mentioned in my presentation in Houston, I had the Blalock-Hanlon procedure during my first surgery in 1967. At that time it was done regularly – the only way to enlarge or create an Atrial Septal Defect was to open the Right Atrium and use a scalpel or a probe to literally poke a hole. Today the operation has practically been retired, since so much can be done with Catheters. Today’s Heart Parents have never heard of the Waterston Shunt or the Potts Shunt – both operations were dropped when someone thought of a better way.

When someone tells you they have had the Fontan, you should ask them when they had it… it has evolved over the years, and each version has good points and bad points. Protein-Losing Enteropathy (PLE) doesn’t seem to affect anyone except Fontan Survivors, and not all of them. And one day scientists will figure out PLE, or the Fontan will be altered again…. or a better procedure will replace it.

And who knows? Perhaps at a Congenital Heart Defect (CHD) Conference in the year 2041, someone will ask “You had the Fontan? What’s that?”

Open Heart Surgery

July 8, 2010

OVER IN THE LOST AND FOUND DEPARTMENT:

I had to go to the doctor’s office for a blood test this morning. Later, my mother asked how it went.

“No problem,” I said. “The only thing unusual that happened was that I found an iPhone in the waiting room.”

“What’s the difference between your phone and an iPhone?” Mom asked.

“About $600!”

I turned it in at the Reception Desk, so if you have misplaced your very cool mobile phone – and it has an 803 area code – call your doctor’s office!

*******

Have you had Open Heart Surgery? Are you sure? Because sometimes, Open Heart Surgery isn’t open heart surgery.

Say what?

It may seem like a little bit of a pet peeve, but seriously, if you are going to speak intelligently about a medical issue, you need to learn the terminology. I am certainly not perfect – it is an Emergency Department, but I am one of the worst about calling it the Emergency Room. I usually manage to type Department, but say Room. (No male wants to go to the ED.) I worked at a museum for ten years but still spell it musuem… thank goodness for Spellcheck!

Open Heart Surgery is one of those phrases that is specific, but has come into common use almost as a verb or descriptive term. Ever ask someone to Xerox something for you? You can’t do that – you can photocopy something, but Xerox had rather you not use their company name as a verb. (Page down to “The Xerox Trademark”.)

Actual, true “Open Heart Surgery” means that an incision was made in the heart – but the term has come to mean all surgical procedures involving the heart. The Blalock-Taussig shunt, for example, was not an open heart surgery. This was the first planned Congenital surgery, and no one knew what would happen if an incision was made in the heart. No one wanted to even get near the heart, just clamp and cut that Subclavian blood vessel we talked about, Dr. Blalock. Clamp the Pulmonary Artery and sew the two together, and get out. So my 2nd operation was not an open heart procedure.

My first one wasn’t supposed to be either the Glenn shunt of that time required sewing the Superior Vena Cava closed, cutting the right branch of the Pulmonary Artery and then sewing that into the Superior Vena Cava. That would deliver blood going through the Vena Cava not to the heart, but shunt it over to the right lung. For a person to live with Tricuspid Atresia, they must have an Atrial Septal Defect (ASD) and a Ventricular Septal Defect (VSD). There are no exceptions – if you don’t have those two holes the blood can’t find a route through the heart and lungs. My ASD was smaller than it should have been, so Dr. Gott performed the Blalock-Hanlon procedure on me. In the Blalock-Hanlon, you cut into the Right Atrium and use a probe or a scalpel to enlarge (or create) an ASD. So even though it wasn’t part of the original plan, I did have Open Heart Surgery.

Dr. Clarence Dennis was the first person to try to use a Heart-Lung machine and perform Open Heart Surgery in April of 1951. Dennis and his team thought they were going to be fixing a simple ASD, but almost as soon as the heart was open they found themselves face-to-face with a severe Heart Defect. Dennis later admitted, “I wasn’t even certain what I was looking at.” They got out quickly and the patient died in Recovery a few hours later.

Dr. John Gibbon was the next person to try Open Heart Surgery, using a Heart-Lung machine of his own design. In the early and mid 1950s all heart lung machines were built as needed and each one of them was different, reflecting the perceived needs of the designer. Pretty much the only thing consistent between all of the machines was the tubing, as a certain beer distributor sold tubing that had a very smooth interior. At one time that company sold to just as many hospitals and individual doctors as they sold to drinking establishments.

Gibbon’s Heart-Lung machine worked and the operation was a success! Positive that he was onto something, Gibbon used the Heart-Lung machine three more times – and failed badly each time, resulting in three deaths. Gibbon was shaken so badly he destroyed his machine, burned the plans, and never operated again.

Dr. Robert Gross, who was operating on children to fix their patent ductus arteriosus (PDA) in 1938, also tried Open Heart Surgery in the 1950′s. His idea didn’t require a Heart-Lung machine at all. Gross’ idea was called the “Arterial Well”, a rubber cone open at both ends. This cone was sewn onto the heart in the area of the needed repair. (The original plan was to use it to repair ASDs, and after that, Gross and his team would have to think about further uses.)

Reaching down into the well, the surgeon made his incision in the heart. The rubber cone would immediately fill with blood, but since it was both wide and tall, it shouldn’t overflow. The surgeon was then supposed to reach down into the blood, find the ASD (by feel!) and sew it up. The incision would then be closed (again, only by touch) and the blood drained off with a small pump. Once the surgeon was satisfied that there were no leaks, the Arterial Well could be removed and the blood replaced by IV.

As you might imagine, that idea didn’t work out very well!

Dr. John Lewis fixed an ASD in 1952. Lewis used Hypothermia  – once sedated, the patient was placed in a large tub of ice. The hypothermia worked, but not for long; the heartbeat was slow enough for surgery for only about 10 minutes. In the room with Dr, Lewis was C. Walton Lillehei, who had some ideas of his own. Lillehei used a cross circulation technique – someone of the same blood type (preferably a close relative) lay on a table next to the patient. Lilllehei would stop the patient’s heart, using the second person as a living Heart-Lung machine! Blood would flow through connections and tubes from the patient to the 2nd person, then back to the patient’s body. Although there was always the possibility that something could go wrong and kill the patient and the volunteer, this setup worked. It wasn’t perfect (most of the patients who passed away died from pneumonia, an all too  common occurance in the early days of heart surgery) but the success rate was more than 50%. Lillehei also had a discussion with Earl Bakken about some kind of electronic device that could regulate a heartbeat. Bakken went home and designed the first pacemaker in his garage – and eventually formed Medtronic! Working with Dr. Richard DeWall, the two developed yet another Heart-Lung machine in 1955. This one worked – and it worked so well that from 1955 until the 1970′s, the Lillehei-DeWall Oxygenator was the top of the line model.

So if you’ve had Open Heart Surgery, take a moment to reflect on all the effort – and lives – it took to get it right.

WOMB-too

July 1, 2010

The first time I heard my heart “speak” was in 1977. I figured that it couldn’t speak English, but I knew that it made some type of sound that an expert could understand. I mean, every time I had ever been to see a doctor, one or more people has placed a stethoscope against my chest. Something’s got to be ratting around in there, right?

On my first full day at the University of Alabama at Birmingham (UAB) Hospital my Cardiologist, Dr. Lionel Barjaron, asked if he could “tape” my heart. I was sort of expecting something to do with medical tape, but they lay me on a table and did the usual Stethoscope against the chest routine. But this stethoscope was attached to a microphone, and that was attached to a tape recorder. They thanked me half a dozen times, and told me that the tape would go to the medical school for the doctors-in-training to listen to. My strange plumbing gave off sounds that would tip a doctor to a problem, and obviously the vast majority of hearts are healthy and don’t produce the sounds they were looking for.

“You want to hear what it sounds like?” Dr. Barjaron asked, and turned on a speaker. “WOMB-too,” it kept repeating over and over, the first sound exactly like the word womb and the second sound like the word tooth with the th left off.

And though I hadn’t realized it, this was not the first time I had ever heard my heart speak. I was told that the heart beat – the “lub-dub” sound we are all familiar with – is caused by the valves slamming shut after the heart chambers fill with blood.

A week later it was the same room, and the same stethoscope/microphone.

“We have to do this again?” I asked. It hadn’t hurt, but I figured the recording had been a one time event.

“You’ve had surgery, and now your heart is making different sounds,” Dr. Barjaron responded. “We’d like to record those, too.” As proof he turned the speaker on again. “You hear the difference?”

“Not really,” I said. To me, it was the same “WOMB-too” as before.

“You just haven’t had any lessons on what to listen for, but to me it sounds a lot different from a week ago,” the Cardiologist assured me. “You’ll just have to trust me on that one.”

Maybe it picked up Dr. Pacifico’s  accent, I thought, thinking about my surgeon’s Brooklyn born voice.

So for a while my heart’s voice lived in my body, but also on a tape at the UAB Medical School. It’s probably gone now; that was 1977, after all. And while I own a stethoscope and have heard both healthy and sick hearts speak, I don’t know what they are saying. It’s a subtle language, the language of the heart, and can be easily misinterpreted.

But my heart can say whatever it wants, as long as it just keeps on talking.

New gene therapy for Heart Failure shows promise

June 28, 2010

A new option for combating Heart Failure (or Congestive Heart Failure, also known as CHF) is showing promise as the CUPID Study

Heart Failure occurs with the heart muscle begins to wear out and lose its elastic properties. It isn’t a Congenital Heart Defect (CHD) itself, but a CHD can trigger it as a patient becomes older. And since I have CHF, I’m interested in keeping an eye on it!

The normal heart contains a protein that has a long medical name that I can’t say and can barely type. Thankfully, it is also known as SERCA2a. In a heart going through Heart Failure, the levels of  SERCA2a begin to drop. All is OK for a while, but it is like driving a car without ever checking the oil. You can take care of yourself, eat right, exercise, and write a letter to your mother every week, but if your heart isn’t producing SERCA2a then you’ve got a real problem on your hands. Eventually the CHF wins.

You can’t drink this stuff or take it in pill form. Instead, the gene that makes this protein is inserted into a virus. Not a virus that can make you sick, but acts as a transport mechanism for the gene. The virus (which in its commercial form is called MYDICAR) is inserted directly into the heart by catheter. In the study, there were 39 patients in total and the ones receiving the drug received low, medium, or high doses. And while there were no “adverse outcomes” the results were rather strange. Sometimes patients had the best response to lower doses of the enzyme. That really doesn’t make any sense.

It does look promising, if they can figure out why some people respond better to lower doses of the therapy. But this was a Phase 2 clinical trial studying a limited number of patients. We’ve got a few years to wait before this becomes available.

The Politician who studied CHD

June 27, 2010

Todd Caminish is a Democratic Candidate for the Arizona State Senate.

But in his non-political job, Todd is an Associate Professor at the University of Arizona College of Pharmacy. And right now, he’s part of a team that is studying the connection between Arsenic and Congenital Heart Defects (CHDs). The research is being conducted as part of the University of Arizona’s Superfund Research Program.

But why Superfund? Isn’t that the federal program designed for hazardous substance cleanup? The Superfund programs becomes involved because of Arizona’s mining history. Arizona’s been the home to lots of mining operations throughout the years. Many times, dangerous substances were used to separate the valuable ore from the regular rock. The end of the process resulted in ore that was being mined and the mine tailings – in other words, everything else. All that rock was discarded… and most of it was contaminated.

As a result, there are 350,000 acres of mine tailings in Arizona. A lot of mining companies used Arsenic as part of the separation process, and as a result, a lot of the mine tailings contain dangerous levels of Arsenic.  Some of the chemical seeps into the ground water; while some of it dries to a fine powder that is easily carried on the wind and breathed by anything with a lung.And research is showing that among other things, Arsenic can affect the cellular “triggers” that guide heart development.

Is there a connection? What does the statistics say? Each year, the Arizona Department of Health Services files the Arizona Birth Defects Monitoring Program Report. In the 1996  edition of the Report, (Read it by CLICKING HERE) Arizona reported 133 Cardiac Congenital Anomalies per 10,000 Live Births and Fetal Deaths. (See chart on page 9) How does that compare to the United States national average? According to the March of Dimes, the average number of babies born with a heart defect in the United States is 1 per every 125 births, or 8 in 1000. Arizona’s number works out to 13.3 children affected out of every 1000. The March of Dimes website doesn’t list information concerning CHD Fetal Deaths, but moving from 8 per 1000 to 13.3 per 1000 is a huge jump.Thats 1 CHD Birth per 75 total births, almost as high as the state of Wisconsin.

Bottom Line: Arizona has a Heart Defect problem, and it very well could be caused by the Arsenic left over from old mines.

What do you see?

June 25, 2010

“Through the mirror of my mind…” – Reflections, (1967) Diana Ross and the Supremes

I have a chest full of scars (Long time Funky Heart! readers have seen them) and they don’t bother me. I see them every day in the mirror and I am comfortable with them; but it wasn’t always like that. At one time I didn’t think of them as marks of survival, but as the debris of a real life horror story. I was much too young to remember the aftermath of my first surgery, but I was ten years old when I had my second. I remember that one quite well. I remember not being able to move my left arm without pain and I remember the bloody bandage that covered the incision. In all honesty, I did have a little seepage and there was a small amount of blood. But remember that I was young and I hadn’t been out of surgery that long.

I didn’t want to see them, didn’t want others to see them….and I’m not quite sure when or how it happened, but as time passed I came to appreciate them. They all show that “I’m still here!” Now I won’t pull open my shirt for strangers (You notice that you can’t see my face in that scar photo) but I’m not ashamed of them.

Some of us, however, are never able to make peace with our scars. And they certainly aren’t lesser people because of it; you have to do what is right for you. Thanks to new surgical techniques developed at Children’s Hospital Boston, future CHDers may not have to worry about a chest full of scars.

This really wasn’t intended to reduce scars, far from it. Dr Pedro del Nido started by looking for something – anything – that would avoid placing a young child on a Heart/Lung bypass machine. Long term exposure to the bypass machine can cause damage to a child’s developing brain, and del Nido would prefer to avoid that if at all possible. The technology to make this happen didn’t exist yet, so del Nido pretty much invented it.

His ideas developed two angles, both attacking the problem: superior heart imaging and using robotics in Congenital Cardiac Surgery. The imaging was very important, as a surgeon needs a good look at what is going on inside of a damaged heart before attempting a repair. Previously the only way to see what was going on was to cut the heart open – exactly what they were trying to avoid. Also, the imaging needs to be exceptionally good. An infant’s heart is the size of a walnut, and operating on it requires precision. So your imaging equipment had better be good. It was good, but it wasn’t what the team needed. The doctor needed to see the heart, functioning, in real-time, and preferably in three dimensions. Something that good didn’t exist, so del Nido and his unit decided to make one.

OK, that’s easier said than done. But the video game industry was already doing it, so Boston Children’s got together with a graphics card maker and rebuilt an Ultrasound machine. The surgeon has to wear special glasses to create the 3-d effect, but it works!

And then there was the robotic surgery angle. Making a small incision and doing everything through a Catheter – type device would not only reduce the number of scars, but would allow a surgeon to operate on a beating heart. That in itself would be a challenge in a child’s heart, where there isn’t enough room to change your mind. So the team developed a small tool – and it is small indeed, only a millimeter – that can be inserted into a beating heart and make surgical repairs. The time of surgery is shorter and the recovery takes less time, also.

So maybe the day is coming when you can have heart surgery but not have the scarring that goes along with it.  Don’t laugh, don’t doubt, because it wasn’t that long ago that everyone seemed to have that circular scar on their arm from the Smallpox vaccine. We don’t see those around too much any more – Smallpox was beaten.

We’ll beat Heart Defects one day, too!

Don’t trust me

June 6, 2010

Google Alerts is pretty cool. I can set up a search for a phrase, and whenever Google Alerts finds that phrase on a new (to them) webpage it will send me a link to it. I have several Google Alerts, and one of them searches for the phrase “Congenital Heart Disease”.

I got a link from Google Alerts over the weekend that almost caused me to jump through the roof. I’m not going to give you a link – no need for this idiot to exist, much less get a link from me – but I will quote from his webpage:

Some of our friends/patients have congenital heart disease, meaning genetically they have high cholesterol despite avid exercise, diet, and supplements. However, for those of us who may not have a specific history of heart disease, yet want to prevent it , we should consider what is best for us to do – regardless of our family history. It’s not all about fat and salt, contrary to public opinion and the words of associations such as the American Heart Association.

SAY WHAT? I’ve been living with a heart defect for 43 years and writing this blog for two years. No one has ever said to me (and I have never found in any research) that Congenital Heart Disease causes high cholesterol. But wait, it gets even better!

However, speaking of salt, most people are sodium deficient. There is absolutely nothing wrong (and it actually should be encouraged) with adding salt during your cooking.

WHOA! Anyone been following the news lately? Salt isn’t your friend – especially if you have Congestive Heart Failure (CHF).

You could shake your head and say that the writer just doesn’t know the facts. But that’s not it. A little further down the page, our writer provides the answer to all your health concerns:

You’d be amazed at how a diet and lifestyle change can get you off cholesterol-lowering and high blood pressure medications. Adding natural nutriceuticals/supplements can add even more help.  If you have never received (our services), give us a call at (XXX) XXX XXXX. We would love to help you get on the road to eating healthy for life.

It seems that he isn’t just incorrect, he’s intentionally misleading you in order to sell his product. Here’s the truth of the matter: If you try to “cure” or control a Congenital Heart Defect with a diet plan or nutritional supplements alone, you will die. It can’t be done – heart defects require constant attention and lifelong care. Even those of us with a “simple” Atrial Septal Defect are recommended to get a periodic Cardiology exam.

So here’s what I want you to do – don’t trust me. Assume that I am just some idiot with a keyboard and an Internet connection. Obviously you have a computer; Google your CHD and look up the research for yourself. Learn how to read it (not so hard these days, you can just Google what you don’t understand) and learn, learn, learn! Talk to your doctor at length, pick his/her brain for all the information you can find. Ask questions. Take the answers and use them to think of even more questions to ask.

Remember that the person who is going to be most affected by your health is… you. The doctor is looking out for you, but at the same time, he has other patients to worry about. You probably aren’t in the forefront of their mind. So learn all you can about your health, and get involved in your own care. Take a hands-on approach.

It’s your body, learn how it works and how to take care of it!

Clinical Trial stopped!

June 2, 2010

Pfizer has decided to stop the recruitment of patients into the EMPHASIS-HF drug trial early. That headline should raise some eyebrows, since it means one of two possible outcomes: Early results are either very good or very, very bad.

Thankfully, the results seem to be very good! According to the press release (a 5 page .pdf file) the study reached its “primary efficacy endpoint” early – in other words, the investigators proved what they were looking for. Taking Eplerenone (also known as Inspra) in conjunction with recommended Heart Failure standards of care, lowers incidence of hospitalization and/or death in patients with mild to moderate heart failure. The adverse events (things that went wrong) included a higher level of potassium in 8% of the patients taking Eplerenone and 4% had renal impairment. Renal impairment means that their kidneys stopped functioning, but that condition can occur because of heart failure also. Apparently the incidence of Renal impairment caused by the new drug is not much different from the number of kidney problems cause just by having heart failure. The Clinical Trial was a double-blind test, which lends it even more credibility, as neither the subject or the investigator knew which drug was being used – the Eplerenone or a harmless placebo. When carried out correctly, a double-blind test prevents either the subject or the investigator from being biased.

So what happens now? Don’t expect to be getting a prescription for Eplerenone, the company does not have a license to sell to human subjects. The study was a small one – only 3100 people, if it had reached full enrollment. All patients, no matter which drug they are on, will be informed of the decision to close the study early. Pfizer has asked for permission to move all consenting patients into a larger study of the drug.

Sometimes medical research comes in small increments – baby steps. But you have to walk before you can run!


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