Aortic Valve StenosisFIBROTICNCT05404100
Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
An observational study of Aortic Valve Stenosis and Aortic Valve Replacement, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis
- What is being tested?
- Aortic valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 8 Sep 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients are recruited from Righospitalet, Denmark, when referred to AVR.
Who may be able to join
- Age ≥ 18 years
- Severe aortic valve stenosis (Vmax > 4 m/s and/or mean gradient >40 mmHg)
Who cannot join
- Reduced left ventricular ejection fraction (<50%)
- More than mild left-sided valvular insufficiency
- Previous or planned primary coronary intervention (PCI) or coronary artery by-pass grafting (CABG)
- Persistent atrial fibrillation
- Contraindications for CMR (pregnancy, severe claustrophobia, magnetic metallic implants)
- Pacemaker/ICD
Trial locations and contacts
1 site in 1 country.
About this study
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. However, irreversible myocardial damage, such as replacement fibrosis, leads to increased morbidity and mortality despite treatment. Improved patient selection and timely treatment is thus warranted. T1 mapping, a non-invasive method to quantify myocardial fibrosis by cardiac magnetic resonance (CMR), could be a marker to guide treatment.
Aims: To investigate the change of myocardial fibrosis* in AS patients following AVR and if these changes are associated with disease and/or procedural characteristics.
Read more
Methods: This is an observational clinical trial. Approximately 60 patients with severe AS planned to undergo AVR (either surgical or transcatheter) at Rigshospitalet, Denmark will be included. Participants will undergo CMR before surgery and at a 1-year follow-up. Other assessments include clinical evaluation and blood sampling. The primary end-point is change in T1 values after AVR.
Hypotheses and perspectives: The investigators hypothesize that (1) myocardial fibrosis* will regress in patients undergoing AVR as a group, (2) the degree of myocardial fibrosis is positively correlated with the degree of symptoms, (3) the regression of myocardial fibrosis is greater in patients undergoing TAVR compared to SAVR, and (4) the regression of myocardial fibrosis is greater in patients with tricuspid aortic stenosis compared to bicuspid aortic stenosis. Ultimately, T1 mapping is a potential marker for improved patient selection for the timing of AVR.
- Estimated by T1 mapping
- Conditions
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance, T1 Mapping
- Being tested
- Aortic valve replacement
- Keywords
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance, T1 mapping
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacementProcedure or surgery
SAVR or TAVR
| Study group | Role | What they receive |
|---|---|---|
| Severe aortic valve stenosis | Patients with severe AS, either symptomatic patients planned to undergo AVR as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR), or asymptomatic patients managed with clinical surveillance. Receives: Procedure: Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in T1 values from baseline to follow-up
Measured: Through study completion, an average of 1 year
Secondary outcomes (15)
New York Heart Association (NYHA) Classification
Measured: Through study completion, an average of 1 year
Type of AVR
SAVR or TAVR
Measured: Through study completion, an average of 1 year
Native valve
Bicuspid or tricuspid aortic valve
Measured: Through study completion, an average of 1 year
Left ventricular volumes
By cardiac magnetic resonance
Measured: Through study completion, an average of 1 year
Left ventricular mass
By cardiac magnetic resonance
Measured: Through study completion, an average of 1 year
Left ventricular strain
By cardiac magnetic resonance and echocardiography
Measured: Through study completion, an average of 1 year
Late gadolinium enhancement
By cardiac magnetic resonance
Measured: Through study completion, an average of 1 year
Extracellular volume
By cardiac magnetic resonance
Measured: Through study completion, an average of 1 year
Left ventricular ejection fraction
By cardiac magnetic resonance and echocardiography
Measured: Through study completion, an average of 1 year
Left atrial size
By cardiac magnetic resonance and echocardiography
Measured: Through study completion, an average of 1 year
e' velocity
By echocardiography
Measured: Through study completion, an average of 1 year
E/e' ratio
By echocardiography
Measured: Through study completion, an average of 1 year
Tricuspid regurgitation velocity
By echocardiography
Measured: Through study completion, an average of 1 year
Concentration of NT-Pro-BNP
Measured: Through study completion, an average of 1 year
Concentration of Troponin T
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Apr 2021
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cardiovascular Academy (DCA), Eva og Henry Frænkels Mindefond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
- Responsible party
- Principal investigator, Katrine Aagaard Myhr, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404100
- Sponsor's protocol ID
- H-20029458
- Acronym
- FIBROTIC
- Status last verified
- Mar 2026
- First submitted
- 25 May 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT05404100
- Acronym / sponsor ID
- FIBROTIC / H-20029458
- Conditions
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance, T1 Mapping
- Keywords
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance, T1 mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cardiovascular Academy (DCA), Eva og Henry Frænkels Mindefond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 3 Jun 2022 (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.
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. However, irreversible myocardial damage, such as replacement fibrosis, leads to increased morbidity and mortality despite treatment. Improved patient selection and timely treatment is thus warranted. T1 mapping, a non-invasive method to quantify myocardial fibrosis by cardiac magnetic resonance (CMR), could be a marker to guide treatment.
Aims: To investigate the change of myocardial fibrosis* in AS patients following AVR and if these changes are associated with disease and/or procedural characteristics.
Methods: This is an observational clinical trial. Approximately 60 patients with severe AS planned to undergo AVR (either surgical or transcatheter) at Rigshospitalet, Denmark will be included. Participants will undergo CMR before surgery and at a 1-year follow-up. Other assessments include clinical evaluation and blood sampling. The primary end-point is change in T1 values after AVR.
Hypotheses and perspectives: The investigators hypothesize that (1) myocardial fibrosis* will regress in patients undergoing AVR as a group, (2) the degree of myocardial fibrosis is positively correlated with the degree of symptoms, (3) the regression of myocardial fibrosis is greater in patients undergoing TAVR compared to SAVR, and (4) the regression of myocardial fibrosis is greater in patients with tricuspid aortic stenosis compared to bicuspid aortic stenosis. Ultimately, T1 mapping is a potential marker for improved patient selection for the timing of AVR.
- Estimated by T1 mapping
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe aortic valve stenosis | – | Procedure: Aortic valve replacementPatients with severe AS, either symptomatic patients planned to undergo AVR as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR), or asymptomatic patients managed with clinical surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from Righospitalet, Denmark, when referred to AVR.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Severe aortic valve stenosis (Vmax > 4 m/s and/or mean gradient >40 mmHg)
Key exclusion criteria (6 listed)
- Reduced left ventricular ejection fraction (<50%)
- More than mild left-sided valvular insufficiency
- Previous or planned primary coronary intervention (PCI) or coronary artery by-pass grafting (CABG)
- Persistent atrial fibrillation
- Contraindications for CMR (pregnancy, severe claustrophobia, magnetic metallic implants)
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 |
|---|---|---|
| Aortic valve replacementSAVR or TAVR | Procedure or surgery | Severe aortic valve stenosis |
Primary outcome
Change in T1 values from baseline to follow-up
Time frame: Through study completion, an average of 1 year
15 secondary outcomes
New York Heart Association (NYHA) Classification
Time frame: Through study completion, an average of 1 year
Type of AVR
Time frame: Through study completion, an average of 1 year
Native valve
Time frame: Through study completion, an average of 1 year
Left ventricular volumes
Time frame: Through study completion, an average of 1 year
Left ventricular mass
Time frame: Through study completion, an average of 1 year
Left ventricular strain
Time frame: Through study completion, an average of 1 year
Late gadolinium enhancement
Time frame: Through study completion, an average of 1 year
Extracellular volume
Time frame: Through study completion, an average of 1 year
Left ventricular ejection fraction
Time frame: Through study completion, an average of 1 year
Left atrial size
Time frame: Through study completion, an average of 1 year
e' velocity
Time frame: Through study completion, an average of 1 year
E/e' ratio
Time frame: Through study completion, an average of 1 year
Tricuspid regurgitation velocity
Time frame: Through study completion, an average of 1 year
Concentration of NT-Pro-BNP
Time frame: Through study completion, an average of 1 year
Concentration of Troponin T
Time frame: Through study completion, an average of 1 year
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 11 Mar 2026.
- Individual participant dataSharing planned: Yes. Data can be provided upon request
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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 and Aortic Valve Replacement, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 6 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 11 Mar 2026. 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 Denmark. 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?
Change in T1 values from baseline to follow-up (time frame: Through study completion, an average of 1 year). 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 Mar 2026.