The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260285

Enrollment

Registered

2010-12-15

Start date

2010-12-31

Completion date

2011-10-31

Last updated

2011-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia-reperfusion Injury.

Brief summary

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

Interventions

DRUGVardenafil

10 mg PO once

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Hypotension	approximately 5 days

Secondary

Measure	Time frame
Ejection Fraction	approximately 5-7 days postop

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026