| Trial ID: | L5583 |
| Source ID: | NCT00692237
|
| Associated Drug: |
Sildenafil
|
| Title: |
Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes
|
| Acronym: |
CECSID
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00692237/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Endothelial Dysfunction
|
| Interventions: |
DRUG: Sildenafil|DRUG: Placebo
|
| Outcome Measures: |
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)., Diabetic cardiomyopathy and hypertrophy are characterized by an increase in cardiac torsion Normal value of rotation are \< 12°; in hypertrophic heart such values can raise up to 20-25°. A reduction in left ventricular wall rotation is a sign of improvement after removal of known causes of hypertrophy (for example after surgical repair of aortic stenosis). Based on previous studies a reduction of 3 degrees (°) is considered clinically significant., 0 and + 3 months | 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)., The volume of blood within a ventricle immediately before a contraction is known as the end-diastolic volume; the volume of blood left in a ventricle at the end of contraction is end-systolic volume. The difference between end-diastolic volume and end-systolic volumes is the volume of blood ejected with each beat. Ejection fraction (Ef) is the fraction of the end-diastolic volume that is ejected with each beat; expressed as percentage of EDV. This is a measure of cardiac performance that can be deteriorated in diabetic cardiomyopathy., 0 and + 3 months
|
| Sponsor/Collaborators: |
Sponsor: University of Roma La Sapienza
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
59
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01
|
| Completion Date: |
2009-12
|
| Results First Posted: |
2012-05-15
|
| Last Update Posted: |
2013-05-08
|
| Locations: |
Dipartimento di Fisiopatologia Medica - Policlinico Umberto I, Rome, 00161, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT00692237
|
