Cardiac Amyloidosis in HFpEF Tunisian Patients

NCT06201832 | Unknown

• 1 other identifier: 13-2023
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identify imaging criteria predictive of cardiac amyloidosis on CMR and echocardiography

  one year

• Frequency of different types of cardiac amyloidosis

  one year

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Security Hospital Forces

La Marsa, Tunis Governorate, 2070, Tunisia

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Disease

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lilia Zakhama, Prof

  University of Tunis El Manar, Faculty of Medicine of Tunis, Tunisia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilia Zakhama, Prof

CONTACT

98345427; lilia.zakhama@fmt.utm.tn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: January 11, 2024
• Study Start: July 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

TU (1)