Transthyretin Cardiac AmyloidosisNCT06257485
Bronx Transthyretin Amyloid Cardiomyopathy Database
An observational study of Transthyretin Cardiac Amyloidosis and Transthyretin Amyloid Cardiomyopathy, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a commonly undiagnosed and potentially fatal disease. Contemporary studies on this condition often underrepresent the female gender and diverse patient populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Cardiac Amyloidosis, Transthyretin Amyloid Cardiomyopathy
- What is being tested?
- 99mTc-pyrophosphate Single Photon Emission Computed Tomography
- How many people
- 476 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023 who had a transthoracic echocardiogram in our medical records.
Who may be able to join
- All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023
Who cannot join
- Did not have a transthoracic echocardiogram in our medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Database of Transthyretin Amyloid Cardiomyopathy Cases in a Racially and Ethnically Diverse Population in the Bronx
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a commonly undiagnosed and potentially fatal disease. Contemporary studies on this condition often underrepresent the female gender and diverse patient populations. This registry retrospectively evaluated patients referred for 99mTc-pyrophosphate (PYP) Single Photon Emission Computed Tomography (SPECT) between 2014 and 2023 at Montefiore-Einstein in the Bronx. The patient population is racially and ethnically diverse and with a high proportion of females. Demographic, clinical (e.g. comorbidities), laboratory, echocardiographic, hospitalization, and mortality data were collected for each patient.
- Being tested
- 99mTc-pyrophosphate Single Photon Emission Computed Tomography
- Keywords
- transthyretin cardiac amyloidosis, transthyretin amyloid cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-pyrophosphate Single Photon Emission Computed TomographyDiagnostic test
All patients underwent 99mTc-pyrophosphate Single Photon Emission Computed Tomography and had a baseline echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography | Patients with suspected transthyretin cardiac amyloidosis referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography Receives: Diagnostic Test: 99mTc-pyrophosphate Single Photon Emission Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATTR-CM Diagnosis
The number of patients who underwent a PYP SPECT scan diagnostic of ATTR-CM will be assessed and reported
Measured: During the index PYP scan within the study time frame parameters of the retrospective review (between 2014 and 2023)
Mortality
The number of patients who died from all-cause mortality will be tabulated and reported
Measured: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Secondary outcomes (2)
Heart failure hospitalizations
The number of patients admitted to the hospital with a primary diagnosis of heart failure will be tabulated and reported
Measured: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Total Hospitalizations
The number of patients admitted to the hospital with any diagnosis will be tabulated and reported
Measured: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start23 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leandro Slipczuk, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257485
- Sponsor's protocol ID
- 2023-15264
- Other IDs
- 2023
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Database of Transthyretin Amyloid Cardiomyopathy Cases in a Racially and Ethnically Diverse Population in the Bronx
- ClinicalTrials.gov ID
- NCT06257485
- Acronym / sponsor ID
- 2023-15264
- Keywords
- transthyretin cardiac amyloidosis, transthyretin amyloid cardiomyopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (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.
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a commonly undiagnosed and potentially fatal disease. Contemporary studies on this condition often underrepresent the female gender and diverse patient populations. This registry retrospectively evaluated patients referred for 99mTc-pyrophosphate (PYP) Single Photon Emission Computed Tomography (SPECT) between 2014 and 2023 at Montefiore-Einstein in the Bronx. The patient population is racially and ethnically diverse and with a high proportion of females. Demographic, clinical (e.g. comorbidities), laboratory, echocardiographic, hospitalization, and mortality data were collected for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography | – | Diagnostic Test: 99mTc-pyrophosphate Single Photon Emission Computed TomographyPatients with suspected transthyretin cardiac amyloidosis referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023 who had a transthoracic echocardiogram in our medical records.
Key inclusion criteria (1 listed)
- All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023
Key exclusion criteria (1 listed)
- Did not have a transthoracic echocardiogram in our medical records
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 |
|---|---|---|
| 99mTc-pyrophosphate Single Photon Emission Computed TomographyAll patients underwent 99mTc-pyrophosphate Single Photon Emission Computed Tomography and had a baseline echocardiogram | Diagnostic test | Patients referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography |
Primary outcome
ATTR-CM Diagnosis
Time frame: During the index PYP scan within the study time frame parameters of the retrospective review (between 2014 and 2023)
The number of patients who underwent a PYP SPECT scan diagnostic of ATTR-CM will be assessed and reported
Mortality
Time frame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
The number of patients who died from all-cause mortality will be tabulated and reported
2 secondary outcomes
Heart failure hospitalizations
Time frame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Total Hospitalizations
Time frame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Performance of Clinical Scoring Systems in the Diagnosis of Transthyretin Amyloid Cardiomyopathy in a Diverse Patient CohortLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Transthyretin Cardiac Amyloidosis
Active, not recruitingPhase 3
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Not yet recruitingObservational study
PET/CT Imaging in Carriers of TTR Mutations
ATTR, ATTR Gene Mutation
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Not yet recruitingPhase 2
Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Transthyretin Cardiac Amyloidosis
Not yet recruitingObservational study
PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
Amyloidogenic Transthyretin (ATTR) Amyloidosis, Cardiac Amyloidosis
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.
Leandro Slipczuk, MD principal investigator
Montefiore Medical Center
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 Transthyretin Cardiac Amyloidosis and Transthyretin Amyloid Cardiomyopathy, run by Montefiore Medical Center at 1 site in United States.
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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
ATTR-CM Diagnosis (time frame: During the index PYP scan within the study time frame parameters of the retrospective review (between 2014 and 2023)). 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 9 Jan 2026.