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The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
McGuire Research Institute
ClinicalTrials.gov Identifier:
NCT01260285
First received: December 10, 2010
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  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
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:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Ion Jovin, MD, McGuire VAMC
ClinicalTrials.gov 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:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Vardenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013