Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM)
Status:
Completed
Trial end date:
2001-02-01
Target enrollment:
Participant gender:
Summary
This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic
cardiomyopathy (HCM), a condition in which the heart muscle thickens. The thickened muscle
can impair the heart's pumping action or decrease its blood supply, or both. Various
symptoms, such as chest pain, shortness of breath, fatigue, and palpitations, may result. In
animal studies, cyclosporine prevented heart muscle from thickening in mice that had been
engineered to develop thick hearts.
Patients with HCM 18 to 75 years old are screened for this study under protocol 98-H-0102 and
this protocol. Screening tests include blood tests, echocardiogram to measure heart
thickness, Holter monitor to record heartbeats, treadmill exercise test, and various imaging
tests including a thallium scan, radionuclide angiography, magnetic resonance imaging (MRI),
and cardiac catheterization to examine heart function and blood supply.
Patients admitted to the study will be randomly assigned to take either cyclosporine tablets
or a placebo (a look-alike tablet with no active ingredient) twice a day for 6 months. During
a brief hospital stay at the start of the study, blood samples will be taken to measure
cyclosporine levels. After discharge, heart rate and blood pressure will be checked and blood
tests done during follow-up visits once a week for 2 weeks and then every two weeks until the
end of the 6-month treatment period. At that time, patients will be hospitalized a second
time for repeat tests to determine the effects of the drug on the heart condition. They
include thallium scan, radionuclide angiogram, MRI, treadmill exercise test, cardiac
catheterization, and echocardiogram. An echocardiogram and MRI will be repeated 1 year after
the start of the study to evaluate long term effects of the drug, if any.