Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction, where chronic nitric oxide deprivation, hyperglycaemia and hyperinsulinemia and fibrogenic mediators lead to cardiovascular remodelling associated with diabetic cardiomyopathy and in consequence to secondary complications of diabetes. Specific anti-oxidative and anti-fibrotic therapies are not currently available. Sildenafil (Viagra) has demonstrated the capability of significantly improving endothelial dysfunction and cardiac fibrosis in experimental animal models.

The purpose of the present study is performed to establish the effect of chronic high dose sildenafil treatment on heart performance in diabetic subjects.

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

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

• Patients age 35-75

• Metabolic control of diabetes by diet or oral treatment (unmodified in the last 3 months)

• Blood pressure <160/100 mmHg, including subjects with controlled hypertension, treated with ACE-inhibitors/sartans, unmodified in the last 3 months

Exclusion Criteria:

• Participation in another study with an investigational drug or device

• HbA1c >12%

• Alterations during ECG stress examination

• Current use of nitrate agents

• Proliferative retinopathy

• Patients with history of cardiovascular and malignant disease

• Psychosocial disturbance

• Alcohol or drug dependence

• Allergy or hypersensitivity to sildenafil or other Phosphodiesterase inhibitors.