NCT01260285

Brief Summary

The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 4, 2011

Status Verified

November 1, 2011

Enrollment Period

10 months

First QC Date

December 10, 2010

Last Update Submit

November 2, 2011

Conditions

Ischemia-reperfusion Injury.

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    approximately 5 days

Secondary Outcomes (1)

  • Ejection Fraction

    approximately 5-7 days postop

Study Arms (1)

Vardenafil

EXPERIMENTAL
Drug: Vardenafil

Interventions

VardenafilDRUG

10 mg PO once

Vardenafil

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing cardiac surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGuire VAMC

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Ion Jovin, MD

    McGuire VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 15, 2010

Study Start

December 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 4, 2011

Record last verified: 2011-11

Locations

US(1)