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The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01260285
First Posted: December 15, 2010
Last Update Posted: November 4, 2011
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.
Information provided by:
McGuire Research Institute
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

  Eligibility

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
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
  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


Locations
United States, Virginia
McGuire VAMC
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
McGuire Research Institute
Investigators
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 Submitted: December 10, 2010
First Posted: December 15, 2010
Last Update Posted: November 4, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Ischemia
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