Aortic RegurgitationNCT07104968
Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome
An observational study of Aortic Regurgitation, run by Uppsala University at 1 site in Sweden.
Trial summary
This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Regurgitation
- How many people
- 35,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with aortic regurgitation
Who may be able to join
- Patients investigated with echocardiography between January 2003 and March 2025
- Age ≥18 years
- At least minimal aortic regurgitation
- At least one additional echocardiography after the index investigation
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Västmanlands sjukhus Västerås
Västerås
Matthijs Velders, MD PhD, +4621-175947, matthijs.velders@regionvastmanland.se
About this study
This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation
Read the detailed description
Aortic regurgitation is relatively common, with a prevalence of 13% for men and 8,5% for women in the Framingham study (Singh et al). Patients with aortic regurgitation are evaluated regularly with echocardiography to see if progress occurs, and suitable candidates are referred for surgical repair or replacement of the aortic valve.
However, an American study from 2019 showed that only 12% of cases of aortic regurgitation progressed from mild to moderate or severe over a 10 years period (Yang et al). This means that the majority of patients undergo echocardiographic evaluations without a clinical benefit.
It is unclear whether these findings also apply to a Swedish population with the European definitions for aortic regurgitation.
Aim:
To do a retrospective analysis of patients evaluated with echocardiography in Västerås, Sweden between January 2003 and March 2025 to describe the prevalence of aortic regurgitation as well as aortic dilatation, to describe how often progress occurs in patients with mild or moderate aortic regurgitation, and finally to look at factors (clinical, echocardiographic) associated with progress of aortic regurgitation as well as outcome (mortality, MACE, cardiac surgery).
- Conditions
- Aortic Regurgitation
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with aortic regurgitation | Observational study, no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress of aortic regurgitation
Progress of aortic regurgitation from mild to moderate or severe, or moderate to severe. Progress is defined according to current European Society for Cardiology guidelines using a comprehensive echocardiographic assessment
Measured: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Secondary outcomes (4)
Surgical treatment of aortic regurgitation or aortic aneurysm
Surgical treatment of aortic regurgitation or aortic aneurysm
Measured: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Hospitalization for heart failure
Hospitalization for heart failure during follow-up
Measured: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Hospitalization for stroke or myocardial infarction
Composite endpoint
Measured: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
All-cause mortality
All-cause mortality during follow-up
Measured: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västmanland
- Responsible party
- Principal investigator, Pär Hedberg, Region Västmanland
- Investigators
- Matthijs Velders, MD PhD, Principal investigator, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104968
- Sponsor's protocol ID
- 2025-02671-01
- Other IDs
- 2025
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang LT, Enriquez-Sarano M, Michelena HI, Nkomo VT, Scott CG, Bailey KR, Oguz D, Wajih Ullah M, Pellikka PA. Predictors of Progression in Patients With Stage B Aortic Regurgitation. J Am Coll Cardiol. 2019 Nov 19;74(20):2480-2492. doi: 10.1016/j.jacc.2019.08.1058.
PubMed 31727286Singh JP, Evans JC, Levy D, Larson MG, Freed LA, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999 Mar 15;83(6):897-902. doi: 10.1016/s0002-9149(98)01064-9.
PubMed 10190406
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome
- ClinicalTrials.gov ID
- NCT07104968
- Acronym / sponsor ID
- 2025-02671-01
- Conditions
- Aortic Regurgitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35,000 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Region Västmanland
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- 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.
This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation
Detailed description
Aortic regurgitation is relatively common, with a prevalence of 13% for men and 8,5% for women in the Framingham study (Singh et al). Patients with aortic regurgitation are evaluated regularly with echocardiography to see if progress occurs, and suitable candidates are referred for surgical repair or replacement of the aortic valve.
However, an American study from 2019 showed that only 12% of cases of aortic regurgitation progressed from mild to moderate or severe over a 10 years period (Yang et al). This means that the majority of patients undergo echocardiographic evaluations without a clinical benefit.
It is unclear whether these findings also apply to a Swedish population with the European definitions for aortic regurgitation.
Aim:
To do a retrospective analysis of patients evaluated with echocardiography in Västerås, Sweden between January 2003 and March 2025 to describe the prevalence of aortic regurgitation as well as aortic dilatation, to describe how often progress occurs in patients with mild or moderate aortic regurgitation, and finally to look at factors (clinical, echocardiographic) associated with progress of aortic regurgitation as well as outcome (mortality, MACE, cardiac surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with aortic regurgitation | – | –Observational study, no interventions |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with aortic regurgitation
Key inclusion criteria (4 listed)
- Patients investigated with echocardiography between January 2003 and March 2025
- Age ≥18 years
- At least minimal aortic regurgitation
- At least one additional echocardiography after the index investigation
Key exclusion criteria (1 listed)
- Age <18 years
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
Progress of aortic regurgitation
Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Progress of aortic regurgitation from mild to moderate or severe, or moderate to severe. Progress is defined according to current European Society for Cardiology guidelines using a comprehensive echocardiographic assessment
4 secondary outcomes
Surgical treatment of aortic regurgitation or aortic aneurysm
Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Hospitalization for heart failure
Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Hospitalization for stroke or myocardial infarction
Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
All-cause mortality
Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 31727286Yang LT, Enriquez-Sarano M, Michelena HI, Nkomo VT, Scott CG, Bailey KR, Oguz D, Wajih Ullah M, Pellikka PA. Predictors of Progression in Patients With Stage B Aortic Regurgitation. J Am Coll Cardiol. 2019 Nov 19;74(20):2480-2492. doi: 10.1016/j.jacc.2019.08.1058.
- Background: PubMed 10190406Singh JP, Evans JC, Levy D, Larson MG, Freed LA, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999 Mar 15;83(6):897-902. doi: 10.1016/s0002-9149(98)01064-9.
- Individual participant dataSharing planned: Undecided
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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.
Matthijs Velders, MD PhD principal investigator
Region Västmanland
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 Regurgitation, run by Uppsala University 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 4 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: opening soon, as of the sponsor's last update on 5 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthijs Velders, MD PhD (+4621-175947, matthijs.velders@regionvastmanland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress of aortic regurgitation (time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up). 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 NCT07104968, which also lists 2 linked publications.
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 5 Aug 2025.