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
  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:


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
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 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
Wounds and Injuries
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 July 26, 2014