Cardiac AmyloidosisPAPCATNCT04915235
Prevalence and Prognosis of Cardiac Amiloidosis in Turkey
An observational study of Cardiac Amyloidosis, run by Turkish Society of Cardiology at 1 site in Turkey (Türkiye).
Trial summary
Patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Algorithm
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,087 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2020to 31 Dec 2025
- How long will I take part?
- 4 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with left ventricular hypertrophy
Who may be able to join
- Patients with left ventricular hypertrophy without left ventricular pressure or volume (IVS≥13mm)
- Patients with left ventricular hypertrophy and hypertension or aortic stenosis without left ventricular pressure or volume (IVS>15mm)
Who cannot join
- Patients with left ventricular pressure or volume except the ones with aortic stenosis and arterial hypertension
- Patients with sigmoid septum and their hypertrophy limited in sigmoid area
- Patients with highly probable sarcometric hypertrophy cardiomyopathy confirmed with LV morhpology and genetic testing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University Faculty of Medicine
Izmir
Ebru Ozpelit, MD
About this study
Official title: Prevalence and Prognosis of Cardiac Amiloidosis in Turkey- Registry Study
Patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis
- Conditions
- Cardiac Amyloidosis
- Being tested
- Algorithm
- 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.
AlgorithmBehavioural
Algorithm
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Amyloidosis
Patients with left ventricular hypertrophy and Cardiac Amyloidosis
Measured: Upon screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start18 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,087 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Turkish Society of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915235
- Sponsor's protocol ID
- PAPCAT
- Acronym
- PAPCAT
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Prognosis of Cardiac Amiloidosis in Turkey- Registry Study
- ClinicalTrials.gov ID
- NCT04915235
- Acronym / sponsor ID
- PAPCAT / PAPCAT
- Conditions
- Cardiac Amyloidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,087 participants (estimated)
- Lead sponsor
- Turkish Society of CardiologyUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jun 2021 (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.
Patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with left ventricular hypertrophy
Key inclusion criteria (2 listed)
- Patients with left ventricular hypertrophy without left ventricular pressure or volume (IVS≥13mm)
- Patients with left ventricular hypertrophy and hypertension or aortic stenosis without left ventricular pressure or volume (IVS>15mm)
Key exclusion criteria (3 listed)
- Patients with left ventricular pressure or volume except the ones with aortic stenosis and arterial hypertension
- Patients with sigmoid septum and their hypertrophy limited in sigmoid area
- Patients with highly probable sarcometric hypertrophy cardiomyopathy confirmed with LV morhpology and genetic testing
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 |
|---|---|---|
| AlgorithmAlgorithm | Behavioural | – |
Primary outcome
Cardiac Amyloidosis
Time frame: Upon screening
Patients with left ventricular hypertrophy and Cardiac Amyloidosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
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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.
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 Cardiac Amyloidosis, run by Turkish Society of Cardiology at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 7 Jun 2021. 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 Turkey (Türkiye). 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?
Contact Ilkay Gucuk, MD (902122211738, tkd@tkd.org.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Amyloidosis (time frame: Upon screening). 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 7 Jun 2021.