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The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

This study has been completed.
Information provided by:
McGuire Research Institute Identifier:
First received: December 10, 2010
Last updated: November 2, 2011
Last verified: November 2011
The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.

Condition Intervention Phase
Ischemia-reperfusion Injury.
Drug: Vardenafil
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by McGuire Research Institute:

Primary Outcome Measures:
  • Hypotension [ Time Frame: approximately 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ejection Fraction [ Time Frame: approximately 5-7 days postop ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vardenafil Drug: Vardenafil
10 mg PO once


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01260285     History of Changes
Other Study ID Numbers: 01703 
Study First Received: December 10, 2010
Last Updated: November 2, 2011
Health Authority: United States: Institutional Review Board

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 processed this record on October 20, 2016