Phase 4 Completed N=59 Randomized Double-blind Treatment

Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes

Type 2 Diabetes Mellitus · Endothelial Dysfunction

Source: ClinicalTrials.gov NCT00692237 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

May 2012

Primary outcomePrimary: Left Ventricular Torsion Defined as Change in Ventricular Mid-wall Rotation (°) Measured by Cine-Cardiac Magnetic Resonance (CMR) Imaging With Tagging, Before and After Three Months of Treatment With Sildenafil and Placebo (100 mg/Day). — -3.89; 2.13 Degree angle (delta)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Left Ventricular Torsion Defined as Change in Ventricular Mid-wall Rotation (°) Measured by Cine-Cardiac Magnetic Resonance (CMR) Imaging With Tagging, Before and After Three Months of Treatment With Sildenafil and Placebo (100 mg/Day).	-3.89; 2.13	—
SECONDARY Ejection Fraction (EF) Defined as the Volume of Blood Ejected With Each Beat Was Measured on Cine-Cardiac Magnetic Resonance (CMR) Images Before and After Three Months Treatment With Sildenafil and Placebo (100 mg/Day).	2.77; 3.14	—

Eligibility 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 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.

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Data sourced from ClinicalTrials.gov (NCT00692237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.