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

Recruiting

• Conditions: Amyloid Cardiomyopathy; Wild Type ATTR Amyloidosis
• Interventions: Other: Interview

• Registration Number: NCT06261216
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-02-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls	Interview	-
wild-type transthyretin amyloid cardiomyopathy	Interview	-
heart failure with reduced ejection fraction	Interview	ischemic or inflammatory origin
heart failure with preserved ejection fraction	Interview	-

Primary Outcome Measures

Name	Time	Method
Association between lifetime physical activity (in METs) and disease development	3rd to 6th decade	Association between lifetime physical activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy

Secondary Outcome Measures

Name	Time	Method
Association between lifetime athletic activity (in METs) and disease development	3rd to 6th decade	Association between lifetime athletic activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria