REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs

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.

Timeline

Start

2014-05

Primary completion

2019-01

Completion

2019-07

Publications

• Pofi R, Giannetta E, Feola T, Galea N, Barbagallo F, Campolo F, Badagliacca R, Barbano B, Ciolina F, Defeudis G, Filardi T, Sesti F, Minnetti M, Vizza CD, Pasqualetti P, Caboni P, Carbone I, Francone M, Catalano C, Pozzilli P, Lenzi A, Venneri MA, Gianfrilli D, Isidori AM. Sex-specific effects of daily tadalafil on diabetic heart kinetics in RECOGITO, a randomized, double-blind, placebo-controlled trial. Sci Transl Med. 2022 Jun 15;14(649):eabl8503. doi: 10.1126/scitranslmed.abl8503. Epub 2022 Jun 15.

Drugs

Indications