Evaluating the Effect of Spironolactone on Hypertrophic Cardiomyopathy
Status:
Unknown status
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
Hypertrophic Cardiomyopathy (HCM) is the most common hereditary heart disease with high
mortality. Heart failure is the most common complication (about 50% incidence) in these
patients. However, it is lack of efficiency medicine to treat heart failure for HCM patients.
Recent studies found fibrosis was common in HCM patients and it was progressive with aging.
Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to
measure the left ventricular(LV) fibrosis extent and been proven to be useful in HCM
patients.
Aldosterone plays an important role in the development of fibrosis. Meanwhile, a few studies
suggested that aldosterone might participate the development of fibrosis in HCM patients.
Spironolactone, a mineralocorticoid receptor antagonist, has been proven its effect on
inceasing the survival of the heart-failure patients with the eject fraction lower than 35%.
Thus, the investigators hypothesize that fibrosis is one important reason of heart failure
for HCM patients. The purpose of this study is to investigate whether small dosage and early
prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis
progress and improve patients' symptoms.
This study is a multicenter, randomized, controlled and open-label study being conducted in 4
centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy of
spironolactone on relieving the LV fibrosis in HCM patients. This study plans to recruit 260
participants with definite HCM diagnosis. Then these participants will be randomized to two
groups-- "control group "(not taking spironolactone) and "spironolactone group" (taking 20mg
spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter,
electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium, liver
enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random allocation
and after 2 years. LGE-CMR will be used to measure the extent of fibrosis in LV. The extent
of LGE+% (the area showing LGE divided by the total area) before and after 2-year experiment
and the increase of LGE+% after 2-year experiment will be compared between control and
spironolactone groups. Meanwhile, symptoms, New York Heart Association classification of
cardiac function, arrhythmia, proBNP and TnT etc. will be compared between two groups.
Phase:
Phase 4
Details
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine