Cardiac Amyloidosis in HFpEF Tunisian Patients

Recruiting

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

• Registration Number: NCT06201832
• Lead Sponsor: University Tunis El Manar

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-31
• Status Verified: 2024-01
• Study First Posted: 2024-01-11
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-07-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of cardiac amyloidosis among HFpEF old Tunisian Patients	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 Outcome Measures

Name	Time	Method
Frequency of different types of cardiac amyloidosis	one year
Identify imaging criteria predictive of cardiac amyloidosis on CMR and echocardiography	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.

Trial Locations

Locations (1)

Security Hospital Forces; 🇹🇳 La Marsa, Tunis, Tunisia