search
Back to results

The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Primary Purpose

Ischemia-reperfusion Injury.

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vardenafil
Sponsored by
McGuire Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia-reperfusion Injury.

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • McGuire VAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vardenafil

Arm Description

Outcomes

Primary Outcome Measures

Hypotension

Secondary Outcome Measures

Ejection Fraction

Full Information

First Posted
December 10, 2010
Last Updated
November 2, 2011
Sponsor
McGuire Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01260285
Brief Title
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
Official Title
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McGuire Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia-reperfusion Injury.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vardenafil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vardenafil
Intervention Description
10 mg PO once
Primary Outcome Measure Information:
Title
Hypotension
Time Frame
approximately 5 days
Secondary Outcome Measure Information:
Title
Ejection Fraction
Time Frame
approximately 5-7 days postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ion Jovin, MD
Organizational Affiliation
McGuire VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGuire VAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

We'll reach out to this number within 24 hrs