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OpenTrials
Completed

NCT Number: NCT06201832

Cardiac Amyloidosis in HFpEF Tunisian Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Identify imaging criteria predictive of cardiac amyloidosis on CMR and echocardiography

    Time frame: one year

    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.

  2. Frequency of different types of cardiac amyloidosis

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Prevalence of Cardiac Amyloidosis in Heart Failure Patients With Preserved Left Ventricular Ejection Fraction in Tunisia

Acronym: Amy-Card

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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