Aortic Valve StenosisNCT01939678
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
An observational study of Aortic Valve Stenosis, run by Region Örebro County at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification. A patient population with premature aortic valve calcification treated with aortic valve replacement will be screened for mutations in these specific genes. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 3 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Sep 2019
- Phase
- Observational
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with aortic valve calcification that will be treated with an aortic valve replacement
Who may be able to join
- Patients with aortic valve calcification that will be treated with an aortic valve replacement.
- Age ≤ 65 years.
- Signed and dated informed consent.
Who cannot join
- Inability to provide informed consent
- Earlier radiation therapy of the thorax
- Severe renal disease (patients in treatment with dialysis)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiology, Orebro University Hospital
Örebro, 70185
About this study
The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification. A patient population with premature aortic valve calcification treated with aortic valve replacement will be screened for mutations in these specific genes. Furthermore, aortic valve tissue received from the operations, will be examined for the presence of Na/Pi-cotransporters, and for molecular characterization of the transporters.
- Conditions
- Aortic Valve Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease
Mutations in genes coding for Na/Pi-cotransporters
Measured: At the time of aortic valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2019
- Study completionSep 2019
Why it stopped: Enrollment lower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Frobert, MD, PhD, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939678
- Sponsor's protocol ID
- 2012-12
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2013
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT01939678
- Acronym / sponsor ID
- 2012-12
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment lower than expected
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 11 Sep 2013 (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 investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification. A patient population with premature aortic valve calcification treated with aortic valve replacement will be screened for mutations in these specific genes. Furthermore, aortic valve tissue received from the operations, will be examined for the presence of Na/Pi-cotransporters, and for molecular characterization of the transporters.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aortic valve calcification that will be treated with an aortic valve replacement
Key inclusion criteria (3 listed)
- Patients with aortic valve calcification that will be treated with an aortic valve replacement.
- Age ≤ 65 years.
- Signed and dated informed consent.
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Earlier radiation therapy of the thorax
- Severe renal disease (patients in treatment with dialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease
Time frame: At the time of aortic valve replacement
Mutations in genes coding for Na/Pi-cotransporters
Results and safety
The study was stopped early (reason given: Enrollment lower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Region Örebro County at 1 site in Sweden.
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 3 inclusion and 3 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 11 Sep 2019. 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 Sweden. 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?
The study was stopped early (reason given: Enrollment lower than expected). Results are not available in the source record.
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?
Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease (time frame: At the time of aortic valve replacement). 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 11 Sep 2019.