The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Phase 1

Completed

• Conditions: Ischemia-reperfusion Injury.
• Interventions: Drug: Vardenafil

• Registration Number: NCT01260285
• Lead Sponsor: McGuire Research Institute

Brief Summary

The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-02
• Last Update Posted: 2011-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• undergoing cardiac surgery

Exclusion Criteria

• emergent surgery
• recent MI in past 7 days prior to surgery
• ejection fraction < 35%
• creatinine > 2.0
• prior CVA
• severe COPD
• recent use of nitrates (within past 48 hours prior to surgery)
• prior CABG
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vardenafil	Vardenafil	-

Primary Outcome Measures

Name	Time	Method
Hypotension	approximately 5 days

Secondary Outcome Measures

Name	Time	Method
Ejection Fraction	approximately 5-7 days postop

Trial Locations

Locations (1)

McGuire VAMC; 🇺🇸 Richmond, Virginia, United States