Amyloid CardiomyopathyATTRABNCT05699044
Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation
An observational study of Amyloid Cardiomyopathy and Block, AV, run by Steen Hvitfeldt Poulsen at 1 site in Denmark.
Trial summary
The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block (AV-block) and are admitted for pacemaker implantation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Amyloid Cardiomyopathy, Block, AV
- What is being tested?
- Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)
- How many people
- 170 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 1 Oct 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: Patients admitted for pacemakerimplantation with advanced AV-block fulfilling eligibility criteria as described.
Who may be able to join
- Men ≥65years or women ≥75years with unexplained AV-block with pacemaker indication, as decided per treating physician and presence of left ventricular hypertrophy ≥12mm.
Who cannot join
- Reversible causes for AV-block, som as AV-node disturbing medicament, ion-disturbances, hypothyroidism, hypoxia, ischemia, new heart surgery <1month, endocarditis.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology, Aarhus University Hospital
Aarhus, 8200
Jens Skov, MD, 20749381 ext. +45, jesmds@rm.dk
Steen Poulsen, MD, 30922309 ext. +45, steenhvitfeldtpoulsen@gmail.com
About this study
Official title: Prevalence, Characteristics and Prognosis of Transthyretin Amyloidosis in Patients With New-onset Advanced AV-block - A National Screening Study
The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block (AV-block) and are admitted for pacemaker implantation. The investigators aim to characterize the group of patients with positive screening of ATTR and compare the ATTRwt disease stage at time of diagnosis for patients identified with ATTR at screening with a control group of routinely clinically diagnosed ATTRwt patients.
- Conditions
- Amyloid Cardiomyopathy, Block, AV
- Being tested
- Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)
- Medical subject headings
- Amyloid Neuropathies, Familial, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)Diagnostic test
Bloodtest: Troponin I, NT-pro-BNP, electrolyte status, renal function, kampda/lambda free chain + ratio, M-komponent.
DPD-scintigraphy. (Echocardiography)
| Study group | Role | What they receive |
|---|---|---|
| Amyloidosis Screening | Patients fulfilling eligibility criteria will screened for Cardiac Amyloidosis. Receives: Diagnostic Test: Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of ATTRwt in study cohort.
Number of participants with a diagnosis of ATTRwt in the study cohort based on DPD-scintigraphy or if necessary, a cardiac biopsy.
Measured: 3 years
Secondary outcomes (4)
Characteristics of patients with ATTRwt
Echocardiographic (Left ventricular (LV) wall thickness, LV cavity dimension, EF, GLS, diastolic function, Right Ventricular (RV) systolic function, valve disease) Biochemical profile (Troponin I, NT-pro-BNP, Renal Function (E-GFR) ), presence or history of spinal stenosis, carpal tunnel syndrome
Measured: 3 years
Clinical Stage of time of diagnosis in patients with ATTRwt
Gilmore Staging
Measured: 3 years
Number of heart-failure associated hospitalization among ATTRwt patients
Measured: 5 years
All-cause mortality among ATTRwt patients.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid CardiomyopathyStudies 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steen Hvitfeldt Poulsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby
- Investigators
- Steen Poulsen, MD, Principal investigator, Department of Cardiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699044
- Sponsor's protocol ID
- 1-10-72-53-22
- Acronym
- ATTRAB
- Status last verified
- May 2023
- First submitted
- 4 Oct 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Characteristics and Prognosis of Transthyretin Amyloidosis in Patients With New-onset Advanced AV-block - A National Screening Study
- ClinicalTrials.gov ID
- NCT05699044
- Acronym / sponsor ID
- ATTRAB / 1-10-72-53-22
- Conditions
- Amyloid Cardiomyopathy, Block, AV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Steen Hvitfeldt PoulsenUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 26 Jan 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.
The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block (AV-block) and are admitted for pacemaker implantation. The investigators aim to characterize the group of patients with positive screening of ATTR and compare the ATTRwt disease stage at time of diagnosis for patients identified with ATTR at screening with a control group of routinely clinically diagnosed ATTRwt patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amyloidosis Screening | – | Diagnostic Test: Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)Patients fulfilling eligibility criteria will screened for Cardiac Amyloidosis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted for pacemakerimplantation with advanced AV-block fulfilling eligibility criteria as described.
Key inclusion criteria (1 listed)
- Men ≥65years or women ≥75years with unexplained AV-block with pacemaker indication, as decided per treating physician and presence of left ventricular hypertrophy ≥12mm.
Key exclusion criteria (1 listed)
- Reversible causes for AV-block, som as AV-node disturbing medicament, ion-disturbances, hypothyroidism, hypoxia, ischemia, new heart surgery <1month, endocarditis.
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 |
|---|---|---|
| Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)Bloodtest: Troponin I, NT-pro-BNP, electrolyte status, renal function, kampda/lambda free chain + ratio, M-komponent. DPD-scintigraphy. (Echocardiography) | Diagnostic test | Amyloidosis Screening |
Primary outcome
Diagnosis of ATTRwt in study cohort.
Time frame: 3 years
Number of participants with a diagnosis of ATTRwt in the study cohort based on DPD-scintigraphy or if necessary, a cardiac biopsy.
4 secondary outcomes
Characteristics of patients with ATTRwt
Time frame: 3 years
Clinical Stage of time of diagnosis in patients with ATTRwt
Time frame: 3 years
Number of heart-failure associated hospitalization among ATTRwt patients
Time frame: 5 years
All-cause mortality among ATTRwt patients.
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
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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.
Steen Poulsen, MD principal investigator
Department of Cardiology, Aarhus University Hospital
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 Amyloid Cardiomyopathy and Block, AV, run by Steen Hvitfeldt Poulsen 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 1 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 2 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Skov, MD (2074381 ext. +45, jesmds@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of ATTRwt in study cohort. (time frame: 3 years). 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 2 Jun 2023.