TRAMmoniTTR Study Genetic Screening of an At-risk Population for HATTR and Monitoring of TTR Positive Subjects

Launched by CENTOGENE GMBH ROSTOCK · Jul 31, 2017

Keywords

ClinConnect Summary

The TRAMmoniTTR Study is a research trial aimed at understanding a condition called Hereditary Transthyretin Amyloidosis (hATTR), which can affect the nerves and heart. The study seeks to find out how common this condition is among people who may be at risk, as well as to monitor those who have already been diagnosed. It will also look for specific markers (or signs) in the body that could help identify hATTR. The trial is currently recruiting participants across the country.

To be eligible for this study, you need to be at least 18 years old and provide informed consent, meaning you understand the study and agree to participate. You may qualify if you have certain health problems like heart issues, unexplained weight loss, or a family history of hATTR. If you already have a confirmed diagnosis of hATTR or are a close relative of someone who does, you can also participate. Those who join the study can expect to have their health monitored over time, and they will be contributing to important research that could help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent is obtained from the participant
• • The participant is 18 years of age or older
• • The participant has no diagnosis of alcoholism according to international guidelines
• • The participant has not undergone chemotherapy for any carcinoma
• • AND
• The participant is at risk for hATTR due to two or more the factors listed below:
• • cardiomyopathy or polyneuropathy with no obvious etiology atypical Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) or Motor Neuron Disease (MND)
• • autonomic dysfunction
• • hypertrophic cardiomyopathy or heart failure with preserved ejection fraction Left Ventricular Hypertrophy (LVH)
• • bilateral carpal tunnel syndrome
• • spinal stenosis or spinal radiculopathy
• • gait disorders
• • ocular changes involving vitreous opacities
• • unexplained weight loss \>5kg
• • renal abnormalities
• • family history of hATTR
• • based on imaging or biopsy suspected for the wild type TTR (ATTR) and not genetically tested for hATTR
• • OR • The participant is diagnosed with hATTR
• • OR
• • • The participant is a 1st or 2nd degree relative of the TTR positive subject
• • Exclusion Criteria
• • Informed consent is not obtained from the participant
• • The participant is younger than 18 years of age
• • The participant has a diagnosis of alcoholism according to International guidelines
• • The participant has undergone chemotherapy for any carcinoma
• • The participant is not at risk for hATTR