The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

NCT01260285 — Phase 1, Completed, 10 participants, McGuire Research Institute

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Registry	NCT01260285
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	10 (Actual)
Sponsor	McGuire Research Institute (Other)
Conditions	Ischemia-reperfusion Injury.
Interventions	Vardenafil (Drug)
Dates	start 2010-12-01, primary completion 2011-10-01, completion 2011-10-01, first posted 2010-12-15, last updated 2011-11-04
Locations	1 site in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Vardenafil	Experimental	Drug: Vardenafil

Vardenafil (Drug): 10 mg PO once

+Outcome measures

Primary outcomes

Hypotension [approximately 5 days]

Secondary outcomes

Ejection Fraction [approximately 5-7 days postop]

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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

+Locations (1)

Facility	City	Country	Status
McGuire VAMC	Richmond, Virginia	United States

+Investigators

Ion Jovin, MD, Principal investigator, McGuire VAMC

My Notes

Public

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