REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs
Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
Pathophysiology of diabetic cardiomyopathy (DCM) is yet unclear and gender differences at
baseline and a specific treatment have not been indicated. The investigators already
demonstrated the positive impact of phosphodiesterase type 5A (PDE5A) inhibition in men. The
investigators' study aims to characterize DCM, measuring molecular and neuroendocrine
assessment to relate to intramyocardial metabolism and cardiac kinetic. The investigators
will perform a randomized, placebo-controlled, double-blind study enrolling 164 diabetic
patients (females and males) with DCM, to evaluate gender responses to 6 months of PDE5A
inhibitors (PDE5Ai). The investigators' study will describe gender differences in DCM
features. The proposed research will test whether PDE5Ai could become a new target for
antiremodeling drugs and to discover a molecular pathways affected by this class of drugs and
a network of circulating markers for the early diagnosis, monitoring and prediction of
response to treatment of DCM.