Cardiac Amyloidosis in HFpEF Tunisian Patients (Amy-Card)

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.

Study Overview

• Status: Completed
• Conditions: Prevalence; Heart Failure With Preserved Ejection Fraction; Diagnosis; Cardiac Amyloidosis; Echocardiography; CMR; Bone Scintigraphy

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Tunisia
  • Tunis Governorate
    • La Marsa, Tunis Governorate, Tunisia, 2070
      • Security Hospital Forces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• HFpEF during the previous year
• IVS thickness of 12mm or greater

Exclusion Criteria:

• age under 60 years
• Acute coronary syndrome complicated by HFpEF
• Congenital heart disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year
Frequency of different types of cardiac amyloidosis		one year

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Principal Investigator: Lilia Zakhama, Prof, University of Tunis El Manar, Faculty of Medicine of Tunis, Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 31, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Proteostasis Deficiencies; Amyloid Neuropathies; Amyloidosis, Familial; Amyloidosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Disease; Amyloid Neuropathies, Familial
• Other Study ID Numbers: 13-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No