The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
Sponsor
McGuire Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01260285
Collaborator
(none)
10
1
1
10
1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
10 participants
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
Study Start Date
:
Dec 1, 2010
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vardenafil
|
Drug: Vardenafil
10 mg PO once
|
Outcome Measures
Primary Outcome Measures
- Hypotension [approximately 5 days]
Secondary Outcome Measures
- Ejection Fraction [approximately 5-7 days postop]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McGuire VAMC | Richmond | Virginia | United States | 23249 |
Sponsors and Collaborators
- McGuire Research Institute
Investigators
- Principal Investigator: Ion Jovin, MD, McGuire VAMC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01260285
Other Study ID Numbers:
- 01703
First Posted:
Dec 15, 2010
Last Update Posted:
Nov 4, 2011
Last Verified:
Nov 1, 2011