Transthyretin Amyloid CardiomyopathyNCT05896904
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
A study testing Echocardiography in people with Transthyretin Amyloid Cardiomyopathy and Heart Failure, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
Clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy, Heart Failure
- What is being tested?
- Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Sep 2022to 31 Aug 2023
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age >65
- ATTRwt diagnosis for patients, either with DPD-scintigraphy or myocardiac biopsy
- informed consent
Who cannot join
- Alder <65
- No ATTRwt diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction
- Being tested
- Echocardiography
- Keywords
- Heart Failure, Echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography | Experimental | Not described Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraventricular wall thickness
echocardiographic measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start9 Sep 2022
- Primary completion6 Mar 2023
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby
- Investigators
- Valentin R Klarskov, Bachelor, Principal investigator, Clinic of heart diseases, AUH.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896904
- Sponsor's protocol ID
- 1-10-72-380-21
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Jun 2023
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT05896904
- Acronym / sponsor ID
- 1-10-72-380-21
- Keywords
- Heart Failure, Echocardiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 9 Jun 2023 (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.
Clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiography | Experimental | Diagnostic Test: Echocardiography |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age >65
- ATTRwt diagnosis for patients, either with DPD-scintigraphy or myocardiac biopsy
- informed consent
Key exclusion criteria (2 listed)
- Alder <65
- No ATTRwt diagnosis
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 |
|---|---|---|
| EchocardiographyEchocardiography | Diagnostic test | Echocardiography |
Primary outcome
intraventricular wall thickness
Time frame: 1 year
echocardiographic measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Valentin R Klarskov, Bachelor principal investigator
Clinic of heart diseases, AUH.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography in people with Transthyretin Amyloid Cardiomyopathy and Heart Failure, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. 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 Denmark. 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?
Results are not available in the source record.
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?
intraventricular wall thickness (time frame: 1 year). 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 9 Jun 2023.