Bicuspid Aortic ValveNCT01390181
The Effect of Losartan in Bicuspid Aortic Valve Patients
A study testing Cozaar in people with Bicuspid Aortic Valve and Thoracic Aortic Aneurysm, run by University of Michigan at 1 site in United States.
Trial summary
The specific aims of this study are to: Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements >40mm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bicuspid Aortic Valve, Thoracic Aortic Aneurysm
- What is being tested?
- Cozaar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >age 18 years and < 65 years old
- Able to give informed consent
- Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending aorta or sinus of Valsalva >4.0cm
- No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
- Able to safely participate in a 4 week drug washout period if currently taking an angiotensin II receptor blocker or ACE inhibitor.
Who cannot join
- Unable to safely take losartan due to one or more of the following:
- Hypersensitivity to losartan or other angiotensin receptor blockers
- Pregnancy
- Nursing mothers
- History of angioedema
- Hypotension - chronically volume depleted patients
Show all 16Show fewer
- Hepatic or renal impairment (Cr>1.5mg/dL)
- Hyperkalemia (K+>4.8)
- Renal artery stenosis
- Severe congestive heart failure (class III-IV)
- Currently taking potassium supplements or salt substitutes containing potassium
- Currently taking lithium
- Prior surgical intervention to aorta or aortic valve
- Unable or unwilling to give informed consent and follow up with study activities
- Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for hypertension and are therefore unable to or are unwilling to participate in a 4 week drug washout period.
- Females of child bearing who are unwilling to practice adequate birth control throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients
The specific aims of this study are to:
- Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements >40mm.
- Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent.
- In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate
- Conditions
- Bicuspid Aortic Valve, Thoracic Aortic Aneurysm
- Being tested
- Cozaar
- Medical subject headings
- Bicuspid Aortic Valve Disease, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CozaarDrug
Also called Losartan
Angiotensin II Receptor Blocker
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Not described Receives: Drug: Cozaar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Markers Levels
Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), \& Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Due to low enrollment the decision was made to terminate study prior to final data collection for any individual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bicuspid Aortic ValveStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Booher, University of Michigan
- Investigators
- Anna Booher, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390181
- Sponsor's protocol ID
- HUM00048364
- Status last verified
- Mar 2017
- First submitted
- 30 Jun 2011
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients
- ClinicalTrials.gov ID
- NCT01390181
- Acronym / sponsor ID
- HUM00048364
- Conditions
- Bicuspid Aortic Valve, Thoracic Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment the decision was made to terminate study prior to final data collection for any individual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of this study are to:
- Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements >40mm.
- Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent.
- In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Cozaar |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults >age 18 years and < 65 years old
- Able to give informed consent
- Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending aorta or sinus of Valsalva >4.0cm
- No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
- Able to safely participate in a 4 week drug washout period if currently taking an angiotensin II receptor blocker or ACE inhibitor.
Key exclusion criteria (16 listed)
- Unable to safely take losartan due to one or more of the following:
- Prior surgical intervention to aorta or aortic valve
- Unable or unwilling to give informed consent and follow up with study activities
- Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for hypertension and are therefore unable to or are unwilling to participate in a 4 week drug washout period.
- Females of child bearing who are unwilling to practice adequate birth control throughout the study.
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 |
|---|---|---|
| CozaarAlso: LosartanAngiotensin II Receptor Blocker | Drug | Losartan |
Primary outcome
Inflammatory Markers Levels
Time frame: Baseline and 12 months
Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), \& Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anna Booher, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cozaar in people with Bicuspid Aortic Valve and Thoracic Aortic Aneurysm, run by University of Michigan 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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 14 Apr 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inflammatory Markers Levels (time frame: Baseline and 12 months). 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 14 Apr 2017.