Phase 4
N=59
Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes
Diabetes Mellitus, Type 2 · Endothelial Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00692237 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
May 2012
Primary outcome: 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 Degree angle (delta)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sildenafil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Male
- Sponsor
- University of Roma La Sapienza
- Primary completion
- Sep 2009
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 | — |
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.
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.
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.