Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection FractionTETRAMERNCT06338839
Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia
An observational study of Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction, run by AstraZeneca at 21 sites in Russia.
Trial summary
A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction
- How many people
- 1,770 participants
- Where
- 21 sitesRussia
- Study dates
- 28 Dec 2023to 25 Jun 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: Planned study population consists of approximately 6000 patients with HFpEF who are participating/participated in the PRIORITY-CHF study and will be enrolled to this study across 140 clinical centers in different regions of Russia, in order to provide a representative study sample. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The patients will be included to the current study consecutively, from the earliest date of start of participation in the PRIORITY-CHF study.
Who may be able to join
- for the retrospective phase are:
- Patients participating/participated in the PRIORITY-CHF study (may be alive or deceased at the time of inclusion to this study).
- Established diagnosis of HFpEF (presence of typical signs and symptoms of HF (see Appendix A) and LVEF ≥50%) at any time during participation in the PRIORITY-CHF study.
- The following criteria apply for inclusion of patients into the prospective part of the study:
- Provided written informed consent for the prospective phase of the study.
- Presence of left ventricular wall thickness >12 mm.
Show all 33Show fewer
- Presence of at least three of "red flags" or additional signs for having high-risk of ATTR-CM (evaluation based on medical history of HF and concomitant diseases, family history, results of previous ECG, Echo-CG/cardiac MRI, laboratory data):
- >65 age (during participation in the PRIORITY-CHF study)
- Conduction system disease (atrioventricular block, left bundle branch block, long QRS complex, sick sinus syndrome)/pacemaker
- Atrial fibrillation
- Pseudoinfarct pattern on the ECG (when hemodynamically significant stenosis is absent);
- Disproportion of QRS voltage to the degree of increased LV wall thickness on imaging methods
- Grade 2 or worse diastolic dysfunction
- Decreased longitudinal strain with apical sparing
- Diffuse subendocardial or transmural late gadolinium enhancement on cardiac MRI with increased extracellular volume fraction
- Persistent low-level troponin elevation
- Elevated NT-proBNP level
- Right ventricular (RV) wall thickness more than 6 mm
- Pericardial effusion in patients with LV-hypertrophy
- Restrictive pattern in patients with LV-hypertrophy
- Atrial enlargement with the normal ventricular volumes
- Bilateral carpal tunnel syndrome
- Lumbar/cervical spinal stenosis
- Spontaneous biceps tendon rupture
- Hip or knee replacement
- Peripheral neuropathy
- Family history of neuropathy
- Intolerance/poor tolerance to vasodilating antihypertensive medications
- Orthostatic hypotension
- Gastroparesis
- Urinary incontinence (neurogenic bladder), recurrent urinary infections,
- Erectile dysfunction
- Other autonomic dysfunction, such as gastrointestinal motility disorders (constipation, early satiety, chronic diarrhea, nausea/vomiting), syncope, anhidrosis)
Who cannot join
- Any severe condition that, in opinion of the physician, will limit patient's life span to 12 months or less from the inclusion to this study.
- Current participation in any interventional trial (i.e. at the time of inclusion to this study).
- The following criteria apply for exclusion of patients from the prospective part of the study:
- Patients with previously established (and documented) ATTR-CM.
- Patients with previous positive hematological test result on evaluating AL-amyloidosis in the anamnesis (monoclonal protein is identified by SIFE/UIF) and the serum FLC ratio (kappa/lambda) is in outside of the normal range).
- If the hematological test on evaluating AL amyloidosis is negative, or there is no such test performed in the patient's medical history, the patient may be enrolled to this study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Russia21 sites
Research Site
Akhtubinsk
Research Site
Astrakhan
Research Site
Barnaul
Research Site
Beslan
Research Site
Chelyabinsk
Research Site
Izhevsk
Research Site
Kaluga
Research Site
Kazan'
Research Site
Khabarovsk
Research Site
Kirov
Research Site
Krasnodar
Research Site
Nizhny Novgorod
Research Site
Omsk
Research Site
Rostov-on-Don
Research Site
Smolensk
Research Site
Ufa
Research Site
Vladimir
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Yaroslavl
Research Site
Yekaterinburg
About this study
Official title: Multicenter Observational Retrospective-prospective Study of Prevalence and Clinical Characteristics of Transthyretin Amyloidosis Cardiomyopathy in Russian Patients With Heart Failure With Preserved Ejection Fraction in Real Clinical Practice
A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice.
The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis
Read the detailed description
This is a multicenter observational study consisting of retrospective and prospective phases.
Heart failure (HF) - is a clinical syndrome characterised by the presence of typical symptoms (e.g. breathlessness, fatigue and ankle swelling) and signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) caused by a structural and/or functional cardiac abnormality, resulting in a reduced cardiac output and/or elevated intracardiac pressures at rest or during stress.
Cardiac amyloidosis is an underestimated cause of HF and cardiac arrhythmias. Among all most commonly types of cardiac amyloidosis (wild-type or familial TTR and light-chain), the wild-type (Wt) TTR-related amyloidosis (ATTR) is an increasingly recognized cause of HFpEF, and amyloidosis should be considered in the differential diagnosis of this heart failure group of patients.
ATTR-CM is an inexorably progressive and eventually fatal, associated with poor quality of life. Diagnosis is often delayed for many years after symptoms develop. However, recognition of ATTR epidemiology is evolving due to the increased use of cardiac scintigraphy as a noninvasive diagnostic tool. Early identification and intervention are crucial to improve patient outcomes because newly available treatments have been shown to have maximum therapeutic benefit when started in the early stages of the disease. In recent years, contemporary cardiac imaging techniques, including MRI and bone scintigraphy, have altered the diagnostic algorithm for ATTR-CM, which has resulted in increased detection.
Thus country-specific epidemiologic data collection and identification of ATTR-CM is crucial to improve outcomes and quality of life. However, no observational studies on the epidemiology of ATTR-CM in Russian patients with HFpEF have been performed.
Therefore, there is a need to conduct a large-scale observational study to determine the prevalence of ATTR-CM in Russia, obtain information on patients' clinical characteristics, and determine their medical needs. Meanwhile information about epidemiological, ECG, EchoCG, other characteristics and prevalence is crucially important to improve diagnostics of these patients.
In addition, recently molecular genetic testing became available, which is essential to diagnose hereditary ATTR. Earlier recognition of the ATTR type, in turn, may lead to timely treatment initiation and change in the prognostic outlook of ATTR-CM patients.
- Keywords
- Transthyretin amyloidosis cardiomyopathy, heart failure with preserved ejection fraction, ATTR, CM, HFpEF
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ATTR-CM in patients with HFpEF in routine clinical practice in the Russian Federation
In order to achieve primary objective, the proportion of patients with confirmed diagnosis of ATTR-CM (at the end-of-study visit, according to the results of comprehensive cardiologic examination) among patients with HFpEF who were enrolled to retrospective phase and prospective phase of this study will be calculated.
Measured: Up to 12 months
Secondary outcomes (1)
demographic and clinical characteristics, and test results
In order to achieve the secondary objectives, the following demographic and clinical characteristics, and test results (with additional available data as needed) will be assessed in patients who were enrolled to the prospective phase of this study: Mean age (years) at the diagnosis of HFpEF during participation in the PRIORITY-CHF study; Mean age at the diagnosis of ATTR-CM confirmed in this study (assessed in patients with confirmed ATTR-CM); Mean and median time from the diagnosis of HFpEF to the confirmed diagnosis of ATTR-CM (assessed in patients with confirmed ATTR-CM); Distribution of patients by age group sex, race, ethnicity and geographic regions; Mean body mass index (BMI) and proportion of patients with different BMI dimensions; Proportion of patients with a history of unexplained weight loss (≥5 kg) at any point; Mean blood pressure (BP) and heart rate; Proportion of patients with presence of negative lifestyle factors (smoking and alcohol abuse); etc.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start28 Dec 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Why it stopped: The study was suspended after interim analysis to confirm reasonability of further investigation of the population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,770 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338839
- Sponsor's protocol ID
- D8450R00006
- Acronym
- TETRAMER
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Retrospective-prospective Study of Prevalence and Clinical Characteristics of Transthyretin Amyloidosis Cardiomyopathy in Russian Patients With Heart Failure With Preserved Ejection Fraction in Real Clinical Practice
- ClinicalTrials.gov ID
- NCT06338839
- Acronym / sponsor ID
- TETRAMER / D8450R00006
- Keywords
- Transthyretin amyloidosis cardiomyopathy, heart failure with preserved ejection fraction, ATTR, CM, HFpEF
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was suspended after interim analysis to confirm reasonability of further investigation of the population
- Enrolment
- 1,770 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 1 Apr 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.
A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice.
The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis
Detailed description
This is a multicenter observational study consisting of retrospective and prospective phases.
Heart failure (HF) - is a clinical syndrome characterised by the presence of typical symptoms (e.g. breathlessness, fatigue and ankle swelling) and signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) caused by a structural and/or functional cardiac abnormality, resulting in a reduced cardiac output and/or elevated intracardiac pressures at rest or during stress.
Cardiac amyloidosis is an underestimated cause of HF and cardiac arrhythmias. Among all most commonly types of cardiac amyloidosis (wild-type or familial TTR and light-chain), the wild-type (Wt) TTR-related amyloidosis (ATTR) is an increasingly recognized cause of HFpEF, and amyloidosis should be considered in the differential diagnosis of this heart failure group of patients.
ATTR-CM is an inexorably progressive and eventually fatal, associated with poor quality of life. Diagnosis is often delayed for many years after symptoms develop. However, recognition of ATTR epidemiology is evolving due to the increased use of cardiac scintigraphy as a noninvasive diagnostic tool. Early identification and intervention are crucial to improve patient outcomes because newly available treatments have been shown to have maximum therapeutic benefit when started in the early stages of the disease. In recent years, contemporary cardiac imaging techniques, including MRI and bone scintigraphy, have altered the diagnostic algorithm for ATTR-CM, which has resulted in increased detection.
Thus country-specific epidemiologic data collection and identification of ATTR-CM is crucial to improve outcomes and quality of life. However, no observational studies on the epidemiology of ATTR-CM in Russian patients with HFpEF have been performed.
Therefore, there is a need to conduct a large-scale observational study to determine the prevalence of ATTR-CM in Russia, obtain information on patients' clinical characteristics, and determine their medical needs. Meanwhile information about epidemiological, ECG, EchoCG, other characteristics and prevalence is crucially important to improve diagnostics of these patients.
In addition, recently molecular genetic testing became available, which is essential to diagnose hereditary ATTR. Earlier recognition of the ATTR type, in turn, may lead to timely treatment initiation and change in the prognostic outlook of ATTR-CM patients.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Planned study population consists of approximately 6000 patients with HFpEF who are participating/participated in the PRIORITY-CHF study and will be enrolled to this study across 140 clinical centers in different regions of Russia, in order to provide a representative study sample. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The patients will be included to the current study consecutively, from the earliest date of start of participation in the PRIORITY-CHF study.
Key inclusion criteria (33 listed)
- Patients participating/participated in the PRIORITY-CHF study (may be alive or deceased at the time of inclusion to this study).
- Established diagnosis of HFpEF (presence of typical signs and symptoms of HF (see Appendix A) and LVEF ≥50%) at any time during participation in the PRIORITY-CHF study.
- The following criteria apply for inclusion of patients into the prospective part of the study:
- Provided written informed consent for the prospective phase of the study.
- Presence of left ventricular wall thickness >12 mm.
Key exclusion criteria (6 listed)
- Any severe condition that, in opinion of the physician, will limit patient's life span to 12 months or less from the inclusion to this study.
- Current participation in any interventional trial (i.e. at the time of inclusion to this study).
- The following criteria apply for exclusion of patients from the prospective part of the study:
- Patients with previously established (and documented) ATTR-CM.
- Patients with previous positive hematological test result on evaluating AL-amyloidosis in the anamnesis (monoclonal protein is identified by SIFE/UIF) and the serum FLC ratio (kappa/lambda) is in outside of the normal range).
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-CM in patients with HFpEF in routine clinical practice in the Russian Federation
Time frame: Up to 12 months
In order to achieve primary objective, the proportion of patients with confirmed diagnosis of ATTR-CM (at the end-of-study visit, according to the results of comprehensive cardiologic examination) among patients with HFpEF who were enrolled to retrospective phase and prospective phase of this study will be calculated.
1 secondary outcome
demographic and clinical characteristics, and test results
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: The study was suspended after interim analysis to confirm reasonability of further investigation of the population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction, run by AstraZeneca at 21 sites in Russia.
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 33 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Russia. 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?
The study was stopped early (reason given: The study was suspended after interim analysis to confirm reasonability of further investigation of the population). 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?
Prevalence of ATTR-CM in patients with HFpEF in routine clinical practice in the Russian Federation (time frame: Up to 12 months). 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 18 Sep 2025.