Cardiac Amyloidosis in HFpEF Tunisian Patients

Heart Failure With Preserved Ejection Fraction Clinical Trial

— Amy-Card  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201832
• Other study ID #: 13-2023
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University Tunis El Manar
• Contact: Lilia Zakhama, Prof
• Phone: 98345427
• Email: lilia.zakhama[@]fmt.utm.tn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: December 31, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis
• Diagnosis
• Echocardiography
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Prevalence

Locations

Country	Name	City	State
Tunisia	Security Hospital Forces	La Marsa	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Frequency of different types of cardiac amyloidosis		one year