Clinical trial NCT06261216: Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy
Official title: Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyloid Cardiomyopathy
Wild Type ATTR Amyloidosis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2024-02-15
Enrollment: 189
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Number of participants: 189 The study population will comprise three subgroups (n=63 in each group)

1. cardiac wild type transthyretin amyloidosis (wtATTR-CM);
2. heart failure (HF);
3. healthy individuals without heart disease

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.

Detailed description: Transthyretin amyloidosis is considered to be the most common cause of cardiac amyloidosis, with an increasing diagnosis rate over the last decade. Though once considered to be a rare disease, recent data suggest it is underappreciated as a common cause of cardiac diseases and syndromes such as left ventricular hypertrophy, aortic stenosis, and heart failure with preserved ejection fraction, especially in the elderly. Wild-type transthyretin amyloidosis, which is associated with ageing, is currently considered to be the most frequent form of amyloidosis worldwide, and is dominated by cardiac symptoms. Other than male gender and advanced age, risk factors for the development of wild-type transthyretin amyloid cardiomyopathy (wtATTR-CM) are largely unknown. There is rising empirical observation that patients with wtATTR-CM frequently have a substantial history of athletic activity, which might contribute to the manifestation of the disease.

This study aims to create evidence of a correlation between increased lifetime physical activity and the development of wtATTR-CM. Furthermore, the investigators aim to explore the association between certain sport disciplines and disease development.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of severe chronic illness limiting the ability to perform physical activity during the 3rd to 6th decade
2. A diagnosis of dementia or cognitive impairment
3. Any other reason resulting in the inability to perform the questionnaire and/or interview
4. Known disease-causing variant (pathogenic or likely-pathogenic) in the TTR gene

Primary outcomes:
measure: Association between lifetime physical activity (in METs) and disease development
timeFrame: 3rd to 6th decade
Secondary outcomes:
measure: Association between lifetime athletic activity (in METs) and disease development
timeFrame: 3rd to 6th decade
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Nicolas Verheyen, Res Prof, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: