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Eplerenone study - moving along nicely

http://www.clinicaltrials.gov/ct2/show/NCT01521546?term=cardiomyopa...

My son had his 6-month appt with OSU last week in this trial. Best news that I can share is that they have already enrolled 38 out of the 40 subjects they need, less than 1 year from the start. We were #13, and we started in September 2012 so this is quite a brisk pace indeed.

The team at OSU is truly world-class I can say that with confidence.

Results are expected about 1 year from now. There are some indications of an open-label extension trial starting up even before then, but nothing official has been announced.

-David

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Permalink Reply by Ofelia Marin on March 18, 2013 at 4:30pm

This is early treatment before any heart modifications correct? Is this used in combination with lisinopril or alone? I first thought that they plan to study the combination.

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Permalink Reply by David on March 18, 2013 at 4:53pm

Not a combination therapy. Not sure what you mean by "heart modifications."

You may be confusing this with some other cardiac studies involving losartan/lisinopril comparisons, or other combinations. This trial specifically looks at Eplerenone via cardiac MRI.

Coincidentally, my son does take losartan, but that is not part of any trial and when we disclosed that to OSU they said "no problem".

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Permalink Reply by Ofelia Marin on March 19, 2013 at 11:59am

What I meant was before heart disease, asymptomatic. And this where they use lisinopril+spironolactone (same class as eplerenone): http://www.ncbi.nlm.nih.gov/pubmed/21768542

It is also research performed at OSU and I had hoped that they actually do a clinical trial testing the early treatment with this combination.

David said:

Not a combination therapy. Not sure what you mean by "heart modifications."

You may be confusing this with some other cardiac studies involving losartan/lisinopril comparisons, or other combinations. This trial specifically looks at Eplerenone via cardiac MRI.

Coincidentally, my son does take losartan, but that is not part of any trial and when we disclosed that to OSU they said "no problem".

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Permalink Reply by David on March 19, 2013 at 1:41pm

Ok, yes I know what you mean now. Yes this trial is for asymptomatic patients. My son has not been diagnosed with cardiomyopathy or ever suffered from a cardiac event.

To qualify for the trial the initial MRI must show at least some scar tissue, since the primary outcome measure is the reduction of scar tissue as seen on MRI.

I think Dr. Raman, who is leading our trial, is involved in the work you mention, but this trial doesn't mention lisinopril and the only drug administered to us is Eplerenone.