TTRACK Study - Hypertrophic cardiomyopathy from undiagnosed etiology
Research type
Research Study
Full title
Prevalence and characteristics of transthyretin amyloidosis in patients with left ventricular hypertrophy of unknown etiology TTRACK
IRAS ID
237632
Contact name
Delphine BLANC
Contact email
Sponsor organisation
Pfizer International Operations
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
This is a multinational, multicentre epidemiological and observational study which will be conducted by experienced cardiologists on patients clinically diagnosed with Hypertrophic Cardiomyopathy (HCM). HCM is a heart muscle disease where the muscle wall of the heart becomes thickened and affects the heart’s ability to pump properly. The purpose of this study is to collect information about the proportion of HCM patients who have:
• Transthyretin (TTR)-related heart disease. Transthyretin is a protein found in the blood
• Family members with a known history of heart disease, nerve disease or sudden cardiac death
• Other signs and symptoms of TTR amyloid build up in the body
• Genetic TTR mutations or wild-type genes
This is an observational study which means that no additional treatments or procedures to a participant's normal routine treatment will be involved. The study is designed to enroll 1500 patients who are at least 50 years old within a period of 12 months across 15 different countries. Data will be collected, analysed, and stratified according to age, gender and cardiac symptoms at the beginning. Eligible participants will provide details of their medical history, month & year of birth, weight, height, ethnic origin, family history and results from a previous ECG and Echocardiogram. A routine bone scan will be performed to assess cardiac retention. Patients with a positive retention grade will be selected to complete a questionnaire about specific signs and symptoms and asked to provide a blood and a urine sample for further genetic analyses of the biological indicators of the disease. Patients identified as having Transthyretin amyloid cardiomyopathy (TTR-CM) will be compared against those who screen negative for the condition and the result will help in identifying possible diagnostic symptoms and factors associated with this condition.Participation to a genetic optional sub study is offered to participants of the main study.
REC name
North of Scotland Research Ethics Committee 1
REC reference
18/NS/0009
Date of REC Opinion
26 Apr 2018
REC opinion
Further Information Favourable Opinion