Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338839
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-04
Brief Title:
Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TETRAMER
Brief 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
The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participatingparticipated 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
The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participatingparticipated 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 eg breathlessness fatigue and ankle swelling and signs eg elevated jugular venous pressure pulmonary crackles and peripheral oedema caused by a structural andor functional cardiac abnormality resulting in a reduced cardiac output andor 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
Heart failure HF - is a clinical syndrome characterised by the presence of typical symptoms eg breathlessness fatigue and ankle swelling and signs eg elevated jugular venous pressure pulmonary crackles and peripheral oedema caused by a structural andor functional cardiac abnormality resulting in a reduced cardiac output andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None