Ischemia-reperfusion Injury.Phase 1NCT01260285
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
A Phase 1 study testing Vardenafil in people with Ischemia-reperfusion Injury., run by McGuire Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemia-reperfusion Injury.
- What is being tested?
- Vardenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing cardiac surgery
Who cannot join
- emergent surgery
- recent MI in past 7 days prior to surgery
- ejection fraction < 35%
- creatinine > 2.0
- prior CVA
- severe COPD
Show all 9Show fewer
- recent use of nitrates (within past 48 hours prior to surgery)
- prior CABG
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.
- Conditions
- Ischemia-reperfusion Injury.
- Being tested
- Vardenafil
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardenafilDrug
10 mg PO once
| Study group | Role | What they receive |
|---|---|---|
| Vardenafil | Experimental | Not described Receives: Drug: Vardenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Measured: approximately 5 days
Secondary outcomes (1)
Ejection Fraction
Measured: approximately 5-7 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-reperfusion Injury.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGuire Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Ion Jovin, MD, Principal investigator, McGuire VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260285
- Sponsor's protocol ID
- 01703
- Status last verified
- Nov 2011
- First submitted
- 10 Dec 2010
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01260285
- Acronym / sponsor ID
- 01703
- Conditions
- Ischemia-reperfusion Injury.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McGuire Research InstituteUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vardenafil | Experimental | Drug: Vardenafil |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing cardiac surgery
Key exclusion criteria (9 listed)
- emergent surgery
- recent MI in past 7 days prior to surgery
- ejection fraction < 35%
- creatinine > 2.0
- prior CVA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vardenafil10 mg PO once | Drug | Vardenafil |
Primary outcome
Hypotension
Time frame: approximately 5 days
1 secondary outcome
Ejection Fraction
Time frame: approximately 5-7 days postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ion Jovin, MD principal investigator
McGuire VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vardenafil in people with Ischemia-reperfusion Injury., run by McGuire Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotension (time frame: approximately 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.