The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

McGuire Research Institute

Status and phase: Completed; Phase 1

Conditions: Ischemia-reperfusion Injury.

Treatments: Drug: Vardenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01260285

01703

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Vardenafil

Experimental group

Treatment:

Drug: Vardenafil