Clinical Research Studies
PITT0908 - Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies
Craig McDonald, M.D.
Erica Goude, MS, CCRP
The purpose of this study is to see if people with certain types of muscular dystrophy who are given Coenzyme Q10 (a nutritional supplement) or lisinopril (a drug) have fewer heart problems compared to people who receive enhanced standard care without being given a drug or nutritional supplement.
Four study arms: 1) Enhanced Standard of Care, 2) Lisinopril daily, 3) Coenzyme Q10 daily, 4) Both Lisinopril and Coenzyme Q10 daily.
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- 8 years of age or older
- Confirmed genetic diagnosis of Duchenne, Becker, or Limb Girdle muscular dystrophy
- Beta-blocker naïve
- Screening Doppler echocardiographic MPI measurement greater than 0.40
- Normal left ventricular fractional shortening (≥28%) and no clinical cardiac symptoms
- Has not participated in other therapeutic research protocol within the last 6 months prior to screening
- Ability to swallow tablets
- Spine curvature greater than 30% (based on the x-ray performed at screening)
- History of significant concomitant illness or significant impairment of renal or hepatic function
- History of hypersensitivity to ACE inhibitors
- History of idiopathic or hereditary angioedema or a history of angioedema with prior ACE inhibitor use
- Use of carnitine, creatine, glutamine, or any herbal medicines (this would not include herbal teas unless they are consumed daily with intended medicinal effect) in the 3-months prior to enrollment
- CoQ10 and/or ACE inhibitor use for a duration greater than 6 months
- CoQ10 and/or ACE inhibitor use in the 3-months prior to enrollment
- CoQ10 serum level of 2.5 ug/ml or higher
- Investigator assessment of inability to comply with protocol