ATTR Amyloidosis Wild TypeNCT06015997
Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR
An observational study of ATTR Amyloidosis Wild Type and Severe Aortic Stenosis, run by Jordan Collaborating Cardiology Group.
Trial summary
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. It is hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- ATTR Amyloidosis Wild Type, Severe Aortic Stenosis, Aortic Valve Stenosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Nov 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Consecutive elderly patients, 65 years of age or older, with a diagnosis of severe aortic stenosis who undergo TAVR will be evaluated for the possible diagnosis of an underlying ATTR cardiac amyloidosis.
Who may be able to join
- Age ≥65 years
- Severe aortic stenosis
- Patient underwent TAVR procedure
- Positive pyruvate PO4 scan
Who cannot join
- Diagnosis of AL amyloidosis base on free light chain assay, serum and urine immune electrophoresis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Prevalence of ATTR Cardiac Amyloidosis in Elderly Middle Eastern Patients Undergoing Transarterial Aortic Valve Replacement
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. It is hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification. Elderly patients undergoing TAVI will be evaluated for the presence of ATTR-CA in Jordan.
Read the detailed description
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. Two hypotheses may explain this association
- Amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification.
- The increased myocardial strain induced by AS may locally favor the process of amyloidogenesis and tissue infiltration.
Transarterial AV replacement (TAVI) is the treatment of choice for elderly patients with severe calcific AS. Studies have shown a prevalence of about 10% of ATTR cardiac amyloidosis in patients undergoing TAVI. The diagnosis is based on a positive nuclear scan (PYP, DPD or HMDP) and ruling out AL amyloidosis in patients with positive scans. While studies have shown no impact of ATTR on prognosis in TAVI patients, there is evidence of poorer quality of life, increased in-hospital acute ischemic stroke, increased cardiac and heart failure hospitalizations, increased conduction abnormalities, compared to patients without ATTR undergoing TAVI.
The prevalence of ATTR in TAVI patients in Jordan and Middle Eastern populations has not been previously evaluated. The purpose of this study is to evaluate the prevalence of ATTR cardiac amyloidosis in elderly Middle Eastern patients undergoing TAVI and to document the clinical characteristics, procedural outcomes and 1 year follow up of such patients compared to patients without ATTR.
- Conditions
- ATTR Amyloidosis Wild Type, Severe Aortic Stenosis, Aortic Valve Stenosis, Middle East Studies
- Keywords
- ATTR cardiac amyloidosis, Severe aortic stenosis, Transarterial aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ATTR CA in TAVR patients
Consecutive elderly (≥65 years) patients who are undergoing TAVI will be included.
Patients will be invited to undergo a pyruvate PO4 (PYP) scan. Patients with positive scans will undergo further testing to rule out AL amyloidosis (Free light chain assay, SIFEP, UIFEP). Data collection will include all pertinent clinical characteristics, peri- procedural details.
Measured: On admission ( from time of admission to time of discharge from the hospital) and within 10 days.
Cardiovascular event at One year follow up
Events at one year defined as the occurrence of all-cause death, and hospital admission for heart failure or aortic valve reintervention.
Measured: One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATTR Amyloidosis Wild TypeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015997
- Sponsor's protocol ID
- ANAC.JO.2023.ATTR.TAVR.ME
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of ATTR Cardiac Amyloidosis in Elderly Middle Eastern Patients Undergoing Transarterial Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT06015997
- Acronym / sponsor ID
- ANAC.JO.2023.ATTR.TAVR.ME
- Conditions
- ATTR Amyloidosis Wild Type, Severe Aortic Stenosis, Aortic Valve Stenosis, Middle East Studies
- Keywords
- ATTR cardiac amyloidosis, Severe aortic stenosis, Transarterial aortic valve replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 29 Aug 2023 (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.
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. It is hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification. Elderly patients undergoing TAVI will be evaluated for the presence of ATTR-CA in Jordan.
Detailed description
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. Two hypotheses may explain this association
- Amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification.
- The increased myocardial strain induced by AS may locally favor the process of amyloidogenesis and tissue infiltration.
Transarterial AV replacement (TAVI) is the treatment of choice for elderly patients with severe calcific AS. Studies have shown a prevalence of about 10% of ATTR cardiac amyloidosis in patients undergoing TAVI. The diagnosis is based on a positive nuclear scan (PYP, DPD or HMDP) and ruling out AL amyloidosis in patients with positive scans. While studies have shown no impact of ATTR on prognosis in TAVI patients, there is evidence of poorer quality of life, increased in-hospital acute ischemic stroke, increased cardiac and heart failure hospitalizations, increased conduction abnormalities, compared to patients without ATTR undergoing TAVI.
The prevalence of ATTR in TAVI patients in Jordan and Middle Eastern populations has not been previously evaluated. The purpose of this study is to evaluate the prevalence of ATTR cardiac amyloidosis in elderly Middle Eastern patients undergoing TAVI and to document the clinical characteristics, procedural outcomes and 1 year follow up of such patients compared to patients without ATTR.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Consecutive elderly patients, 65 years of age or older, with a diagnosis of severe aortic stenosis who undergo TAVR will be evaluated for the possible diagnosis of an underlying ATTR cardiac amyloidosis.
Key inclusion criteria (4 listed)
- Age ≥65 years
- Severe aortic stenosis
- Patient underwent TAVR procedure
- Positive pyruvate PO4 scan
Key exclusion criteria (1 listed)
- Diagnosis of AL amyloidosis base on free light chain assay, serum and urine immune electrophoresis.
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
Prevalence of ATTR CA in TAVR patients
Time frame: On admission ( from time of admission to time of discharge from the hospital) and within 10 days.
Consecutive elderly (≥65 years) patients who are undergoing TAVI will be included. Patients will be invited to undergo a pyruvate PO4 (PYP) scan. Patients with positive scans will undergo further testing to rule out AL amyloidosis (Free light chain assay, SIFEP, UIFEP). Data collection will include all pertinent clinical characteristics, peri- procedural details.
Cardiovascular event at One year follow up
Time frame: One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure
Events at one year defined as the occurrence of all-cause death, and hospital admission for heart failure or aortic valve reintervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
Related trials for ATTR Amyloidosis Wild Type
RecruitingPhase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Active, not recruitingPhase 3
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Enrolling by invitationPhase 3
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
RecruitingPhase 3
TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis With Cardiomyopathy
RecruitingPhase 4
A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis
Transthyretin Amyloid Cardiomyopathy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of ATTR Amyloidosis Wild Type and Severe Aortic Stenosis, run by Jordan Collaborating Cardiology Group.
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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ramzi Tabbalat, MD, FACC (00962795535522, ramzi_md@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ATTR CA in TAVR patients (time frame: On admission ( from time of admission to time of discharge from the hospital) and within 10 days.). The study lists 2 primary outcomes in all. 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 29 Aug 2023.