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
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
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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
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Vascular Diseases
Vardenafil Dihydrochloride
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents processed this record on May 25, 2016