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Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes (CECSID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea M. Isidori, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00692237
First received: June 4, 2008
Last updated: May 5, 2013
Last verified: May 2013
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Endothelial Dysfunction
Interventions: Drug: Sildenafil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible men were recruited from the outpatient clinics of Policlinico Umberto I - Sapienza University Hospital of Rome between 2008 and 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall 66 patients were eligible and enrolled; Seven were then excluded due to evidence of aneurysm of ascending aorta (1) on stress-Echo and of ischemic heart disease (6) at the first CMR. Fifty-nine patients were randomized.

Reporting Groups
  Description
Sildenafil Sildenafil citrate 100 mg/day (50+25+25)
Placebo Placebo 100 mg/day (50 + 25 + 25)

Participant Flow:   Overall Study
    Sildenafil     Placebo  
STARTED     30     29  
COMPLETED     29     25  
NOT COMPLETED     1     4  
Withdrawal by Subject                 1                 3  
Adverse Event                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sildenafil Sildenafil citrate 100 mg/day (50+25+25)
Placebo Placebo 100 mg/day (50 + 25 + 25)
Total Total of all reporting groups

Baseline Measures
    Sildenafil     Placebo     Total  
Number of Participants  
[units: participants]
  30     29     59  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     10     9     19  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 7     59  ± 7     60  ± 7  
Gender  
[units: participants]
     
Female     0     0     0  
Male     30     29     59  
Region of Enrollment  
[units: participants]
     
Italy     30     29     59  



  Outcome Measures
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1.  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).   [ Time Frame: 0 and + 3 months ]

2.  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).   [ Time Frame: 0 and + 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Andrea Isidori
Organization: Sapienza University of Rome
phone: +39 0649970540
e-mail: andrea.isidori@uniroma1.it


Publications of Results:

Responsible Party: Andrea M. Isidori, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT00692237     History of Changes
Other Study ID Numbers: 746/07
Study First Received: June 4, 2008
Results First Received: August 23, 2011
Last Updated: May 5, 2013
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health