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Losartan vs Lisinopril Trial

Does anyone have more recent information about this trial? Any progress? Is it still enrolling? I cannot find a link for it on Nationwide Children's page anymore.

http://quest.mda.org/print/16556

Losartan vs lisinopril study (DMD only)

The second study is to compare two cardiac drugs, losartan (Cozaar) and lisinopril (Prinivil, Zestril), for their effects on cardiac and skeletal muscle in DMD. Both drugs are approved by the U.S. Food and Drug Administration for treatment of certain types of cardiac problems. Both interfere with the actions of angiotensin, a protein that causes blood vessels to constrict. Interfering with angiotensin causes blood vessels to dilate, decreasing workload for the heart and possibly increasing blood flow to muscles.

The investigators seek to enroll 150 participants with DMD who have a mutation in the dystrophin gene that does not allow any dystrophin production or who have a muscle biopsy showing less than 5 percent of the normal dystrophin level; have a cardiac "ejection fraction" of less than 55 percent; can cooperate for study testing; and are not taking any heart medication at the start of the study.

Participants will have an echocardiogram when they begin the study and then every four months for a year. Skeletal- muscle testing will be done at the start and end of the one-year study. The study ends in December 2012.

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Permalink Reply by cheryl cliff on May 10, 2011 at 5:56pm

Alexander is enrolled in this study. It is to last 1 year and then I heard they are seeking to extend another year for a reason I am not aware of yet. I do believe they are still enrolling throughout the USA. Even though it involves travelling to trial sites it seems as though they are spreading the sites around well enough (at least for us here in Cal) to not have to go to Nationwide for every exam. Our initial appt was at Nationwide via Dr Allen, through Dr Flanigan. For the next exam we will see the peeps at UC Davis. UC Davis has personell who are specifically trained by Dr Allen for this study and all data is sent to him.

Alexander's heart involvement is new and we appreciate the (FREE) extra eco-cardio exams needed for the study. He was going to require meds anyway, during the study and 1 year after (I think they said) we get heart meds (we get to choose which one after the study) for free.

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Permalink Reply by Ofelia Marin on May 11, 2011 at 9:22am

So the study is now under way and they are comparing Losartan and Lisinopril right? It would be good to know which one if any is a "better" alternative and if Losartan helps the skeletal muscles as well (as it did in mice).

I just cannot find it anywhere, not on clinicaltrials.gov either.

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Permalink Reply by Paul Cliff on May 14, 2011 at 10:26am

Ofelia,

The purpose of the study is to compare Lisinopril to Losartan. It used to be at Clinicaltrials.gov, but now I cannot find it either. Jerry Mendel and Kevin Flanigan know about it. I believe that some evidence of cardiac dysfunction is a requirement for participating. Not happy about passing that test.