Aortic StenosisPREDICT-ASNCT01422044
Risk Prediction in Aortic Stenosis
An observational study of Aortic Stenosis, run by Thebiosignals.com at 1 site in Germany.
Trial summary
The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- How many people
- 423 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Jan 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with at least moderate aortic stenosis
Who may be able to join
- Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg
Who cannot join
- life expectancy <1 year due to non-cardiac causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function
The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.
Read the detailed description
Autonomic function will be assessed by presence of severe autonomic failure (defined by combination of abnormal heart rate turbulence and deceleration capacity).
Autonomic function will also be assessed by respiration and repolarization abnormalities.
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, autonomic function
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Total mortality
Measured: 2 years
Secondary outcomes (3)
Cardiovascular mortality
Measured: 2 years
Combination of cardiovascular mortality and cardiac adverse events
Measured: 2 years
Correlation of presence of autonomic dysfunction with severity of aortic stenosis
It will be assessed whether patients with cardiac autonomic dysfunction have more severe aortic stenosis.
Autonomic dysfunction will assumed to be present when patients suffer from "severe autonomic failure" (i.e. combination of abnormal Heart Rate Turbulence and Deceleration Capacity).
Severity of aortic stenosis will be assessed by clinical (symptoms, NYHA class), hemodynamic (mean aortic gradient, aortic valve area) and biochemical (Nt-BNP, high sensitive troponins) markers.
Measured: at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startSep 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thebiosignals.com
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Bauer, Thebiosignals.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422044
- Sponsor's protocol ID
- 402/2009BO2-1
- Acronym
- PREDICT-AS
- Status last verified
- Feb 2014
- First submitted
- 19 Jul 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zuern CS, Eick C, Rizas KD, Stoleriu C, Barthel P, Scherer C, Muller KA, Gawaz M, Bauer A. Severe autonomic failure in moderate to severe aortic stenosis: prevalence and association with hemodynamics and biomarkers. Clin Res Cardiol. 2012 Jul;101(7):565-72. doi: 10.1007/s00392-012-0427-3. Epub 2012 Feb 24.
PubMed 22362502
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function
- ClinicalTrials.gov ID
- NCT01422044
- Acronym / sponsor ID
- PREDICT-AS / 402/2009BO2-1
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, autonomic function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Thebiosignals.comUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Aug 2011 (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 test the prognostic value of autonomic markers in patients with aortic stenosis.
Detailed description
Autonomic function will be assessed by presence of severe autonomic failure (defined by combination of abnormal heart rate turbulence and deceleration capacity).
Autonomic function will also be assessed by respiration and repolarization abnormalities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with at least moderate aortic stenosis
Key inclusion criteria (1 listed)
- Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg
Key exclusion criteria (1 listed)
- life expectancy <1 year due to non-cardiac causes
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
Total mortality
Time frame: 2 years
3 secondary outcomes
Cardiovascular mortality
Time frame: 2 years
Combination of cardiovascular mortality and cardiac adverse events
Time frame: 2 years
Correlation of presence of autonomic dysfunction with severity of aortic stenosis
Time frame: at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission
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 6 Feb 2014.
- Derived from this study: PubMed 22362502Zuern CS, Eick C, Rizas KD, Stoleriu C, Barthel P, Scherer C, Muller KA, Gawaz M, Bauer A. Severe autonomic failure in moderate to severe aortic stenosis: prevalence and association with hemodynamics and biomarkers. Clin Res Cardiol. 2012 Jul;101(7):565-72. doi: 10.1007/s00392-012-0427-3. Epub 2012 Feb 24.
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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 Stenosis, run by Thebiosignals.com at 1 site in Germany.
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 1 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 6 Feb 2014. 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 Germany. 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 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?
Total mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422044, which also lists 1 linked publication.
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 6 Feb 2014.