The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

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

Completed

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Key information

Conditions

Ischemia-reperfusion Injury. Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

McGuire VAMC

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vardenafil

Drug

10 mg PO once

Primary outcomes

Hypotension

Time frame: approximately 5 days

Secondary outcomes

Ejection Fraction

Time frame: approximately 5-7 days postop

Sponsors and collaborators

Lead sponsor

McGuire Research Institute

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 15, 2010
Registry last updated: Nov 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed