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

NCT ID: NCT06261216

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-16

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Amyloid Cardiomyopathy Wild Type ATTR Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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wild-type transthyretin amyloid cardiomyopathy

Interview

Intervention Type OTHER

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

heart failure

Interview

Intervention Type OTHER

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

healthy controls

Interview

Intervention Type OTHER

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

Interventions

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Interview

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Verheyen, Res Prof, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Nicolas Verheyen, Res Prof, MD PhD

Role: CONTACT

0043 316 385 30173

Nora Schwegel, MD

Role: CONTACT

0043 316 385 31414

Facility Contacts

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PI

Role: primary

0043 316 385 30173

Other Identifiers

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01/2023/LPA-wtATTR/NVNS

Identifier Type: -

Identifier Source: org_study_id

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