Amyloid CardiomyopathyNCT06261216
Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy
An observational study of Amyloid Cardiomyopathy and Wild Type ATTR Amyloidosis, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyloid Cardiomyopathy, Wild Type ATTR Amyloidosis
- What is being tested?
- Interview
- How many people
- 180 participants
- Where
- 1 siteAustria
- Study dates
- 16 Feb 2024to 20 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy.
Read the 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.
- Conditions
- Amyloid Cardiomyopathy, Wild Type ATTR Amyloidosis
- Being tested
- Interview
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
- International Physical Activity Questionnaire (IPAQ-SF)
- interviewer-administered modified Lifetime Total Physical Activity Questionnaire (LTPAQ) form
| Study group | Role | What they receive |
|---|---|---|
| wild-type transthyretin amyloid cardiomyopathy | Not described Receives: Other: Interview | |
| heart failure | Not described Receives: Other: Interview | |
| healthy controls | Not described Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3rd to 6th decade
Secondary outcomes (1)
Association between lifetime athletic activity (in METs) and disease development
Association between lifetime athletic activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy
Measured: 3rd to 6th decade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start16 Feb 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor
- Investigators
- Nicolas Verheyen, Res Prof, MD PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261216
- Sponsor's protocol ID
- 01/2023/LPA-wtATTR/NVNS
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06261216
- Acronym / sponsor ID
- 01/2023/LPA-wtATTR/NVNS
- Conditions
- Amyloid Cardiomyopathy, Wild Type ATTR Amyloidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| wild-type transthyretin amyloid cardiomyopathy | – | Other: Interview |
| heart failure | – | Other: Interview |
| healthy controls | – | Other: Interview |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview* International Physical Activity Questionnaire (IPAQ-SF) * interviewer-administered modified Lifetime Total Physical Activity Questionnaire (LTPAQ) form | Other | healthy controls, heart failure, wild-type transthyretin amyloid cardiomyopathy |
Primary outcome
Association between lifetime physical activity (in METs) and disease development
Time frame: 3rd to 6th decade
Association between lifetime physical activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy
1 secondary outcome
Association between lifetime athletic activity (in METs) and disease development
Time frame: 3rd to 6th decade
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Amyloid Cardiomyopathy
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Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
RecruitingPhase 3
CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
RecruitingPhase 4
A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis
Transthyretin Amyloid Cardiomyopathy
Active, not recruitingPhase 2
A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Verheyen, Res Prof, MD PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloid Cardiomyopathy and Wild Type ATTR Amyloidosis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between lifetime physical activity (in METs) and disease development (time frame: 3rd to 6th decade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.