When the test doesn’t work

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?”

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7 Responses to “When the test doesn’t work”

  1. Shannon Carter Says:

    Well isn’t that disappointing! Derrick is on Enalapril to “preserve his ventricular function…” I sure hate to read that. Hopefully they’ll come up with something else soon that is proven to preserve these special little hearts (and big hearts too)!!

    Thanks for the info Steve.

  2. Crystal Says:

    Hi Steve! I’ve found your site about a year ago and have been a regular lurker ever since. My 2 1/2 year old daughter has HLHS with coronary sinusoid cameral fistulas. She has had her BT surgery and Glenn but we are waiting to do her Fontan until next summer. Our choice not necessarily the doctors choice although they said she is doing well clinically so there was no real reason to have the Fontan this year. I had read that the major CHD hospitals were actually waiting to the Fontan until the child was 4-5 years instead of the typical 2 years of age. My question to you is where is this enalapril study documented??? Thanks for the great insight!

  3. jill Says:

    ok so this is going to freak out parents but this study was only done on infants 12 months and under…sooo what about older kids. before anyone makes a big deal out of this i think more research needs to be done on the older children as enalapril is not given to younger babies.. well at least at chob it isnt. they use captopril until they are around 2ish. so this really isnt a suprize.

  4. Crystal Says:

    I spoke with my daughter’s cardiologist (we recently switched docs but within the same practice) this morning and he was very interested in this article. My daughter has been on Enalapril since the BT/Norwood for mild to moderate tricuspid regurd. Our cardiologist told us there is a camp of thinking that if you give the heart support with Enalapril it will last longer but there is no study to prove it. Now at what age will single vent kids benefit from this drugs use? We just don’t have all the answers. Our kids are breaking new ground here and we are floundering to keep up. I think this blog post really hits it home. Everyday new discoveries are being made and better medicines and methods are being developed. Excellent post!

  5. mom2lo Says:

    Hi, Steve!
    I’ve been following your site for months and really appreciate the great info! My almost 10-month-old has HLHS and has been on enalapril since his Glenn at 4 1/2 months old. Just curious if these findings basically mirror this article from last November (http://www.medpagetoday.com/MeetingCoverage/AHA/17032) regarding ALL ace inhibitors failing single ventricle infants, not just enalapril? Curious to get your thoughts on this. I’m planning to ask Chase’s cardiologist his opinion as well.

    Thanks!
    Kathy

    • Steve Says:

      Same authors, same subject matter, it does look like the same report. Important medical news is often released first at a major medical conference – the paper has often been written and submitted for publication. (Legitimate medical journals will have Peer Review – someone who runs the numbers again and double checks the method of study, to prevent questionable science from being published. It can be six months or more from the trial report being submitted to actual publication.)

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