Cardiac AmyloidosisAmy-CardNCT06201832
Cardiac Amyloidosis in HFpEF Tunisian Patients
An observational study of Cardiac Amyloidosis and Heart Failure With Preserved Ejection Fraction, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Cardiac amyloidosis (CA) has recently been reported as a common cause of heart failure with preserved left ventricular ejection fraction (HFpEF), with a prevalence of 6% in elderly HFpEF patients. However, the diagnosis of CA is still challenging and requires multiple costly investigations. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Cardiac Amyloidosis, Heart Failure With Preserved Ejection Fraction, Echocardiography
- How many people
- 87 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jul 2023to 31 Dec 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 years or older, admitted to hospital for HFpEF in the preceding year, and with an IVS thickness of 12 mm or greater.
Who may be able to join
- HFpEF during the previous year
- IVS thickness of 12mm or greater
Who cannot join
- age under 60 years
- Acute coronary syndrome complicated by HFpEF
- Congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Cardiac Amyloidosis in Heart Failure Patients With Preserved Left Ventricular Ejection Fraction in Tunisia
Cardiac amyloidosis (CA) has recently been reported as a common cause of heart failure with preserved left ventricular ejection fraction (HFpEF), with a prevalence of 6% in elderly HFpEF patients. However, the diagnosis of CA is still challenging and requires multiple costly investigations.
Regardless of the type of CA, TTR or AL, early diagnosis significantly improves prognosis.
In this study, the investigators aimed to determine the prevalence of CA in Tunisian HFpEF patients and to identify clinical and ultrasound criteria predictive of CA.
- Conditions
- Cardiac Amyloidosis, Heart Failure With Preserved Ejection Fraction, Echocardiography, CMR, Bone Scintigraphy, Prevalence
- Medical subject headings
- Amyloid Neuropathies, Familial, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiac amyloidosis among HFpEF old Tunisian Patients
Prevalence of cardiac amyloidosis in a Tunisian cohort of HFpEF patients aged 60 years or older with interventricular septal thickness equal to or greater than 12 mm
Measured: one year
Secondary outcomes (2)
Identify imaging criteria predictive of cardiac amyloidosis on CMR and echocardiography
Number of cardiac amyloidosis patients with impaired global longitudinal left ventricular strain and/or impaired left atrial strain on echocardiography and/or elevated extra cellular volume (ECV) on CMR.
Measured: one year
Frequency of different types of cardiac amyloidosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jul 2023
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilia Zakhama, University Tunis El Manar
- Investigators
- Lilia Zakhama, Prof, Principal investigator, University of Tunis El Manar, Faculty of Medicine of Tunis, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201832
- Sponsor's protocol ID
- 13-2023
- Acronym
- Amy-Card
- Status last verified
- May 2026
- First submitted
- 2 Dec 2023
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cardiac Amyloidosis in Heart Failure Patients With Preserved Left Ventricular Ejection Fraction in Tunisia
- ClinicalTrials.gov ID
- NCT06201832
- Acronym / sponsor ID
- Amy-Card / 13-2023
- Conditions
- Cardiac Amyloidosis, Heart Failure With Preserved Ejection Fraction, Echocardiography, CMR, Bone Scintigraphy, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Jan 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.
Cardiac amyloidosis (CA) has recently been reported as a common cause of heart failure with preserved left ventricular ejection fraction (HFpEF), with a prevalence of 6% in elderly HFpEF patients. However, the diagnosis of CA is still challenging and requires multiple costly investigations.
Regardless of the type of CA, TTR or AL, early diagnosis significantly improves prognosis.
In this study, the investigators aimed to determine the prevalence of CA in Tunisian HFpEF patients and to identify clinical and ultrasound criteria predictive of CA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 years or older, admitted to hospital for HFpEF in the preceding year, and with an IVS thickness of 12 mm or greater.
Key inclusion criteria (2 listed)
- HFpEF during the previous year
- IVS thickness of 12mm or greater
Key exclusion criteria (3 listed)
- age under 60 years
- Acute coronary syndrome complicated by HFpEF
- Congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of cardiac amyloidosis among HFpEF old Tunisian Patients
Time frame: one year
Prevalence of cardiac amyloidosis in a Tunisian cohort of HFpEF patients aged 60 years or older with interventricular septal thickness equal to or greater than 12 mm
2 secondary outcomes
Identify imaging criteria predictive of cardiac amyloidosis on CMR and echocardiography
Time frame: one year
Frequency of different types of cardiac amyloidosis
Time frame: one year
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 19 May 2026.
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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.
Lilia Zakhama, Prof principal investigator
University of Tunis El Manar, Faculty of Medicine of Tunis, Tunisia
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 and Heart Failure With Preserved Ejection Fraction, run by University Tunis El Manar at 1 site in Tunisia.
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: finished, as of the sponsor's last update on 19 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 Tunisia. 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?
Prevalence of cardiac amyloidosis among HFpEF old Tunisian Patients (time frame: one 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 19 May 2026.