Aortic Stenosis SymptomaticNCT04061213
ATTR Amyloidosis in Elderly Patients With Aortic Stenosis
An observational study of Aortic Stenosis Symptomatic and Amyloidosis Cardiac, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis Symptomatic, Amyloidosis Cardiac
- What is being tested?
- Tc-99m-DPD scintigraphy
- How many people
- 489 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Aug 2019to Dec 2022
- How long will I take part?
- 10 Years
- 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 symptomatic, severe aortic stenosis undergoing pre-evaluation for (transcatheter) aortic valve replacement
Who may be able to join
- Symptomatic, severe aortic stenosis
Who cannot join
- More than mild valvular disease of any other valve
- Other severe disease with a life expectancy < 1 year
- Participating in trial interfering with routine clinical practice or use of a non-CE marked device
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Bern - Inselspital
Bern, Canton of Bern, 3010
About this study
Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF > 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis.
ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.
- Conditions
- Aortic Stenosis Symptomatic, Amyloidosis Cardiac
- Being tested
- Tc-99m-DPD scintigraphy
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc-99m-DPD scintigraphyDiagnostic test
Myocardial scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptomatic severe aortic stenosis | Elderly patients referred for TAVR evaluation Receives: Diagnostic Test: Tc-99m-DPD scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays
Evaluation of incidence rate
Measured: In-Hospital [7 days]
Secondary outcomes (2)
All-cause and cardiovascular mortality
Clinical Endpoints
Measured: 30 days, 12months
CPET - maximal exercise capacity
Functional Endpoints
Measured: In-Hospital [7 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start26 Aug 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (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 Stenosis SymptomaticStudies 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
- 489 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Stortecky, MD, Principal investigator, Swiss Cardiovascular Center Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061213
- Sponsor's protocol ID
- 4083 / KEK-Nr. 2019-00880
- Status last verified
- Dec 2022
- First submitted
- 15 Aug 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernhard B, Leib Z, Dobner S, Demirel C, Caobelli F, Rominger A, Schutze J, Grogg H, Alwan L, Spano G, Boscolo Berto M, Lanz J, Pilgrim T, Windecker S, Stortecky S, Grani C. Routine 4D Cardiac CT to Identify Concomitant Transthyretin Amyloid Cardiomyopathy in Older Adults with Severe Aortic Stenosis. Radiology. 2023 Dec;309(3):e230425. doi: 10.1148/radiol.230425.
PubMed 38085082Dobner S, Pilgrim T, Hagemeyer D, Heg D, Lanz J, Reusser N, Grani C, Afshar-Oromieh A, Rominger A, Langhammer B, Reineke D, Windecker S, Stortecky S. Amyloid Transthyretin Cardiomyopathy in Elderly Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. J Am Heart Assoc. 2023 Aug 15;12(16):e030271. doi: 10.1161/JAHA.123.030271. Epub 2023 Aug 10.
PubMed 37581394
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATTR Amyloidosis in Elderly Patients With Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04061213
- Acronym / sponsor ID
- 4083 / KEK-Nr. 2019-00880
- Conditions
- Aortic Stenosis Symptomatic, Amyloidosis Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Aug 2019 (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.
Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF > 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis.
ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic severe aortic stenosis | – | Diagnostic Test: Tc-99m-DPD scintigraphyElderly patients referred for TAVR evaluation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic, severe aortic stenosis undergoing pre-evaluation for (transcatheter) aortic valve replacement
Key inclusion criteria (1 listed)
- Symptomatic, severe aortic stenosis
Key exclusion criteria (3 listed)
- More than mild valvular disease of any other valve
- Other severe disease with a life expectancy < 1 year
- Participating in trial interfering with routine clinical practice or use of a non-CE marked device
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 |
|---|---|---|
| Tc-99m-DPD scintigraphyMyocardial scintigraphy | Diagnostic test | Patients with symptomatic severe aortic stenosis |
Primary outcome
Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays
Time frame: In-Hospital [7 days]
Evaluation of incidence rate
2 secondary outcomes
All-cause and cardiovascular mortality
Time frame: 30 days, 12months
CPET - maximal exercise capacity
Time frame: In-Hospital [7 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 38085082Bernhard B, Leib Z, Dobner S, Demirel C, Caobelli F, Rominger A, Schutze J, Grogg H, Alwan L, Spano G, Boscolo Berto M, Lanz J, Pilgrim T, Windecker S, Stortecky S, Grani C. Routine 4D Cardiac CT to Identify Concomitant Transthyretin Amyloid Cardiomyopathy in Older Adults with Severe Aortic Stenosis. Radiology. 2023 Dec;309(3):e230425. doi: 10.1148/radiol.230425.
- Derived from this study: PubMed 37581394Dobner S, Pilgrim T, Hagemeyer D, Heg D, Lanz J, Reusser N, Grani C, Afshar-Oromieh A, Rominger A, Langhammer B, Reineke D, Windecker S, Stortecky S. Amyloid Transthyretin Cardiomyopathy in Elderly Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. J Am Heart Assoc. 2023 Aug 15;12(16):e030271. doi: 10.1161/JAHA.123.030271. Epub 2023 Aug 10.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Stenosis Symptomatic
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Symptomatic Hypertrophic Cardiomyopathy (HCM)
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.
Stefan Stortecky, MD principal investigator
Swiss Cardiovascular Center Bern
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 Symptomatic and Amyloidosis Cardiac, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 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: status not confirmed, as of the sponsor's last update on 15 Dec 2022. 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 Switzerland. 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?
Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays (time frame: In-Hospital [7 days]). 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 NCT04061213, 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 15 Dec 2022.