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The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01260285
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : November 4, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Ischemia-reperfusion Injury. Drug: Vardenafil Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
Study Start Date : December 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Vardenafil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vardenafil Drug: Vardenafil
10 mg PO once

Outcome Measures

Primary Outcome Measures :
  1. Hypotension [ Time Frame: approximately 5 days ]

Secondary Outcome Measures :
  1. Ejection Fraction [ Time Frame: approximately 5-7 days postop ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260285

United States, Virginia
McGuire VAMC
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
McGuire Research Institute
Principal Investigator: Ion Jovin, MD McGuire VAMC
More Information

Responsible Party: Dr. Ion Jovin, MD, McGuire VAMC
ClinicalTrials.gov Identifier: NCT01260285     History of Changes
Other Study ID Numbers: 01703
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: November 4, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents