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

Amyloid Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261216
• Other study ID #: 01/2023/LPA-wtATTR/NVNS
• Status: Recruiting
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Medical University of Graz
• Contact: Nicolas Verheyen, MD PhD
• Phone: 031638530173
• Email: nicolas.verheyen[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, we aim to explore the association between certain sport disciplines and disease development.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Confirmed diagnosis of wtATTR-CM including sequencing of the TTR gene; or HFpEF; or HFrEF; or healthy proband without a diagnosis of heart failure

2. Initial diagnosis of respective cardiac disease (wtATTR-CM, HFpEF, HFrEF) 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

Related Conditions & MeSH terms

• Amyloid Cardiomyopathy
• Amyloidosis
• Cardiomyopathies

Intervention

Other:
• Interview
International Physical Activity Questionnaire (IPAQ-SF) interviewer-administered modified Lifetime Total Physical Activity Questionnaire (LTPAQ) form

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between lifetime physical activity 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	Association between lifetime athletic activity and disease development	Association between lifetime athletic activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy	3rd to 6th decade