REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• age 45-80 years;

• Diagnosis of Type 2 Diabetes from at least 3 years;

• HbA1c < 10%;

• normal blood pressure or controlled hypertension;

• BMI < 40;

• SIV ≥ 11 mm men, ≥ 10 women and/or diastolic dysfunction (PW-doppler and TDI)

Exclusion Criteria:

• current use of PDE5 inhibitors;

• congenital or valvular cardiomyopathy;

• ischemic heart disease;

• proliferative retinopathy;

• contraindications to tadalafil use (hypersensitivity to tadalafil, nitrates use, severe cardiovascular disorders such as unstable angina or severe heart failure, severe hepatic impairment, blood pressure <90/50 mmHg, recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa);

• contraindications to CMR imaging with mdc (patients with implant such as cardiac pacemakers, insulin pumps, neurostimulators and cochlear implants, or metallic fragments, clips or devices, or severe renal failure with GFR < 30mL/min/1.73 m2);

• cronic or acute atrial fibrillation.