Aortic Stenosis, CalcificFIB-ASNCT03585933
Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis
An observational study of Aortic Stenosis, Calcific, run by Vilnius University at 2 sites in 2 countries.
Trial summary
Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Calcific
- What is being tested?
- Cardiac magnetic resonance imaging
- How many people
- 110 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 May 2019to Aug 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe aortic stenosis without significant coronary artery disease (CAD), eligible for aortic valve intervention (SAVR or TAVI).
Who may be able to join
- Severe aortic stenosis (aortic valve area <1.0cm2 or aortic valve area index <0.6 cm2/m2
- Age ≥18 years.
- Signed informed patient consent form.
Who cannot join
- Severe valvular disease other than AS.
- Significant coronary heart disease requiring revascularisation.
- History of myocardial infarction.
- Previous cardiac surgery.
- Severe renal impairment eGFR <30ml/min/1.73m2.
- Any absolute contraindication to CMR.
Show all 13Show fewer
- Inherited or acquired cardiomyopathy.
- Other medical conditions that limits life expectancy or precludes SAVR or TAVI.
- Pregnant or nursing women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- Patients in permanent atrial fibrillation.
- Significant chronic obstructive pulmonary disease (FEV1 <70% of predicted value)
- Patient with implanted devices (pacemaker, ICD)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction and, consequently, to with AS related symptoms. When symptoms associated with AS appear, patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter aortic valve implantation (TAVI) is not performed.
Primary hypothesis of the research: fibrotic changes in the myocardium are related to immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients with severe AS.
The goal of the study is to determine the prognostic implications of focal as well as diffuse myocardial fibrosis in patients with severe aortic valve stenosis.
Read the detailed description
AS is the most common valvular heart condition in the Western world. In response to increased afterload imposed by AS adaptive left ventricular (LV) remodelling occurs which in a course of a disease transitions from LV hypertrophy to maladaptive changes in the myocardium leading to cardiac decompensation and symptoms development. This transition is predominantly driven by myocardial fibrosis and myocyte cell death. Increasing evidence have demonstrated that presence of myocardial fibrosis, detected by cardiovascular magnetic resonance (CMR), could serve as an early marker of LV decompensation and predict adverse outcomes in patients with aortic stenosis. Currently, the indications for valvular replacement are based on the stenosis severity evaluated by echocardiography and the presence of symptoms.
The objective of the project is to identify parameters of non-invasive imaging modalities (two-dimensional echocardiography with an extended myocardial deformation analysis, 1.5 T CMR with T1 parametric map and late gadolinium enhancement (LGE) predictive of cardiac decompensation and to evaluate the prognostic significance of myocardial fibrotic changes in patients with severe degenerative AS. In patients with suspicion of cardiac amyloidosis, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy will be performed.
Study design: a prospective, open, case-driven, multicentre study (Lithuania, Denmark).
Investigators will assess LV structural and functional alterations before and 12 months after aortic valve intervention. Cardiac imaging data will be aligned with histopathological data from myocardial tissue samples collected at the time of aortic valve replacement in SAVR group. In patients with suspicion of cardiac amyloidosis, DPD scintigraphy and further evaluation regarding amyloidosis will be performed.
- Conditions
- Aortic Stenosis, Calcific
- Being tested
- Cardiac magnetic resonance imaging
- Keywords
- Myocardial fibrosis, Severe aortic stenosis, Cardiovascular magnetic resonance, Scintigraphy, SAVR/TAVI
- Medical subject headings
- Aortic Valve, Calcification of, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imagingDiagnostic test
Also called echocardiography, Intra-operative myocardial biopsy
Echocardiography: assessment of aortic stenosis severity, evaluation of LV diastolic and systolic function; CMR: chambers quantification, LGE, T1 mapping; Intraoperative myocardial tissue biopsy for patients undergoing SAVR; DPD scintigraphy: assessment of cardiac transthyretin amyloidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of all-cause mortality and MACE (Acute myocardial infarction, stroke, heart failure requiring hospitalisation)
Measured: 2 years
Secondary outcomes (4)
Cardiovascular mortality
Measured: 2 years
Short term mortality
Intrahospital or 30 days mortality
Measured: 30 days
Lengh of hospital stay
Measured: 30 days
Time to the event ( deathe of MACE)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start8 May 2019
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
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 Stenosis, CalcificStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Sogaard,MD DMSc, Vilnius University
- Investigators
- Peter Sogaard, Prof., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585933
- Sponsor's protocol ID
- 1014
- Other IDs
- 09.3.3-LMT-K-712
- Acronym
- FIB-AS
- Status last verified
- Oct 2022
- First submitted
- 2 Jul 2018
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Balciunaite G, Palionis D, Zurauskas E, Skorniakov V, Janusauskas V, Zorinas A, Zaremba T, Valeviciene N, Aidietis A, Serpytis P, Rucinskas K, Sogaard P, Glaveckaite S. Prognostic value of myocardial fibrosis in severe aortic stenosis: study protocol for a prospective observational multi-center study (FIB-AS). BMC Cardiovasc Disord. 2020 Jun 8;20(1):275. doi: 10.1186/s12872-020-01552-8.
PubMed 32513178
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT03585933
- Acronym / sponsor ID
- FIB-AS / 1014
- Conditions
- Aortic Stenosis, Calcific
- Keywords
- Myocardial fibrosis, Severe aortic stenosis, Cardiovascular magnetic resonance, Scintigraphy, SAVR/TAVI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Jul 2018 (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.
Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction and, consequently, to with AS related symptoms. When symptoms associated with AS appear, patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter aortic valve implantation (TAVI) is not performed.
Primary hypothesis of the research: fibrotic changes in the myocardium are related to immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients with severe AS.
The goal of the study is to determine the prognostic implications of focal as well as diffuse myocardial fibrosis in patients with severe aortic valve stenosis.
Detailed description
AS is the most common valvular heart condition in the Western world. In response to increased afterload imposed by AS adaptive left ventricular (LV) remodelling occurs which in a course of a disease transitions from LV hypertrophy to maladaptive changes in the myocardium leading to cardiac decompensation and symptoms development. This transition is predominantly driven by myocardial fibrosis and myocyte cell death. Increasing evidence have demonstrated that presence of myocardial fibrosis, detected by cardiovascular magnetic resonance (CMR), could serve as an early marker of LV decompensation and predict adverse outcomes in patients with aortic stenosis. Currently, the indications for valvular replacement are based on the stenosis severity evaluated by echocardiography and the presence of symptoms.
The objective of the project is to identify parameters of non-invasive imaging modalities (two-dimensional echocardiography with an extended myocardial deformation analysis, 1.5 T CMR with T1 parametric map and late gadolinium enhancement (LGE) predictive of cardiac decompensation and to evaluate the prognostic significance of myocardial fibrotic changes in patients with severe degenerative AS. In patients with suspicion of cardiac amyloidosis, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy will be performed.
Study design: a prospective, open, case-driven, multicentre study (Lithuania, Denmark).
Investigators will assess LV structural and functional alterations before and 12 months after aortic valve intervention. Cardiac imaging data will be aligned with histopathological data from myocardial tissue samples collected at the time of aortic valve replacement in SAVR group. In patients with suspicion of cardiac amyloidosis, DPD scintigraphy and further evaluation regarding amyloidosis will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe aortic stenosis without significant coronary artery disease (CAD), eligible for aortic valve intervention (SAVR or TAVI).
Key inclusion criteria (3 listed)
- Severe aortic stenosis (aortic valve area <1.0cm2 or aortic valve area index <0.6 cm2/m2
- Age ≥18 years.
- Signed informed patient consent form.
Key exclusion criteria (13 listed)
- Severe valvular disease other than AS.
- Significant coronary heart disease requiring revascularisation.
- History of myocardial infarction.
- Previous cardiac surgery.
- Severe renal impairment eGFR <30ml/min/1.73m2.
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 |
|---|---|---|
| Cardiac magnetic resonance imagingAlso: echocardiography, Intra-operative myocardial biopsyEchocardiography: assessment of aortic stenosis severity, evaluation of LV diastolic and systolic function; CMR: chambers quantification, LGE, T1 mapping; Intraoperative myocardial tissue biopsy for patients undergoing SAVR; DPD scintigraphy: assessment of cardiac transthyretin amyloidosis | Diagnostic test | – |
Primary outcome
A composite of all-cause mortality and MACE (Acute myocardial infarction, stroke, heart failure requiring hospitalisation)
Time frame: 2 years
4 secondary outcomes
Cardiovascular mortality
Time frame: 2 years
Short term mortality
Time frame: 30 days
Lengh of hospital stay
Time frame: 30 days
Time to the event ( deathe of MACE)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 32513178Balciunaite G, Palionis D, Zurauskas E, Skorniakov V, Janusauskas V, Zorinas A, Zaremba T, Valeviciene N, Aidietis A, Serpytis P, Rucinskas K, Sogaard P, Glaveckaite S. Prognostic value of myocardial fibrosis in severe aortic stenosis: study protocol for a prospective observational multi-center study (FIB-AS). BMC Cardiovasc Disord. 2020 Jun 8;20(1):275. doi: 10.1186/s12872-020-01552-8.
- 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. This study is not recruiting at the moment.
Peter Sogaard, Prof. principal investigator
Aalborg University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, Calcific, run by Vilnius University at 2 sites in 2 countries.
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 13 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Lithuania. 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?
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?
A composite of all-cause mortality and MACE (Acute myocardial infarction, stroke, heart failure requiring hospitalisation) (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 NCT03585933, 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 18 Oct 2022.