Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy

NCT06261216 | Completed

• 1 other identifier: 01/2023/LPA-wtATTR/NVNS
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy.

Conditions

Amyloid Cardiomyopathy; Wild Type ATTR Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Association between lifetime physical activity (in METs) and disease development

  Association between lifetime physical activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy

  3rd to 6th decade

Secondary Outcomes (1)

• Association between lifetime athletic activity (in METs) and disease development

  3rd to 6th decade

Study Arms (3)

wild-type transthyretin amyloid cardiomyopathy

Other: Interview

heart failure

Other: Interview

healthy controls

Other: Interview

Interventions

Interview OTHER

* International Physical Activity Questionnaire (IPAQ-SF) * interviewer-administered modified Lifetime Total Physical Activity Questionnaire (LTPAQ) form

healthy controls; heart failure; wild-type transthyretin amyloid cardiomyopathy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Number of participants: 180 The study population will comprise three subgroups (n=60 in each group) 1. cardiac wild type transthyretin amyloidosis (wtATTR-CM); 2. heart failure (HF); 3. healthy individuals without heart disease

You may qualify if:

• Confirmed diagnosis of wtATTR-CM including sequencing of the TTR gene; or HF; or healthy proband without a diagnosis of heart disease\*
• Initial diagnosis of respective cardiac disease (wtATTR-CM, HF) after the 6th decade of life; or no cardiac disease (healthy control)
• Willingness and ability to provide signed informed consent form (ICF)
• Age \> 60 years

You may not qualify if:

• History of severe chronic illness limiting the ability to perform physical activity during the 3rd to 6th decade
• A diagnosis of dementia or cognitive impairment
• Any other reason resulting in the inability to perform the questionnaire and/or interview
• Known disease-causing variant (pathogenic or likely-pathogenic) in the TTR gene
• defined as an individual without one of the following diagnoses:
• Cardiomyopathy of any origin, defined as a myocardial disorder with structural and functional abnormalities in the absence of coronary artery disease, hypertension, valvular disease, and congenital heart disease sufficient to cause the observed myocardial abnormality; or
• Heart failure regardless of aetiology, defined as presence of distinct cardinal symptoms (e.g. breathlessness, ankle swelling, fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure, peripheral oedema), due to a structural and/or functional abnormality of the heart, regardless of systolic function or aetiology; or
• Clinically significant coronary artery disease, defined as 1) a history of coronary intervention; or 2) inducible myocardial ischemia and ischaemic chest pain (angina pectoris) due to flow-limiting stenoses, diffuse atherosclerotic lesions, structural abnormalities, congenital anomalies, dynamic epicardial vasospasm; or
• Clinically significant valvular heart disease, defined as 1) a history of valvular surgery or intervention; or 2) moderate or severe stenosis or regurgitation; or
• Hypertrophic phenotype defined as enddiastolic maximal wall thickness ≥ 15mm; or
• History of arrhythmias or significant conduction disease, defined as ventricular brady- or tachyarrhythmias, atrial flutter or atrial fibrillation, sick sinus syndrome, or atrioventricular block greater than 1st degree block; or
• History of sudden cardiac arrest, defined as sudden cessation of normal cardiac activity with haemodynamic collapse

Sponsors & Collaborators

• Medical University of Graz: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

Medical University of Graz

Graz, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

40mL of blood in aliquots at -80°C

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nicolas Verheyen, Res Prof, MD PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 16, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)