NCT05596643

Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Familial Mediterranean Fever (FMF) is the most common inherited autoinflammatory disease affecting 150,000 patients worldwide. Periodic febrile exacerbations, peritonitis, and pleuritis are characteristic disease features. Dysregulation of IL-1β secretion has an important role in the pathophysiology of the disease, and IL-1β also serves as a therapeutic target. Chronic inflammation has been associated with early atherosclerotic and cardiovascular disease in various rheumatic diseases. An increased risk for cardiovascular events associated with disease activity has been described in rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus. In addition, autonomic nervous system dysfunction may contribute to increased cardiovascular risk in patients with inflammatory disease. For example, decreased heart rate variability is an important feature of cardiac autonomic dysfunction and is an isolated risk factor for cardiovascular events. Autonomic dysfunction studies related to FMF have conflicting results. The aim of this study was to determine autonomic dysfunction symptoms and objective findings in patients with FMF; Demographic characteristics, disease characteristics, inflammatory burden, fatigue level, sleep quality, presence of fibromyalgia and their relationship with quality of life were evaluated and compared with healthy controls.

Conditions

• Familial Mediterranean Fever
• Autonomic Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Composite Autonomic Symptom Score-31	Standardized questionnaire to determine the level of autonomic dysfunction
DIAGNOSTIC_TEST	r-r interval variability with normal breathing	electrophysiological test to detect parasympathetic dysfunction
DIAGNOSTIC_TEST	r-r interval variability with deep breathing	electrophysiological test to detect parasympathetic dysfunction
DIAGNOSTIC_TEST	Valsalva ratio	electrophysiological test to detect parasympathetic dysfunction
DIAGNOSTIC_TEST	30:15 ratio	electrophysiological test to detect parasympathetic dysfunction
DIAGNOSTIC_TEST	sympathetic skin response	electrophysiological test to detect sympathetic dysfunction
DIAGNOSTIC_TEST	blood pressure response to standing	clinical test to detect sympathetic dysfunction
DIAGNOSTIC_TEST	blood pressure response to sustained handgrip test	clinical test to detect sympathetic dysfunction
OTHER	Hospital anxiety and depression scale	Standardized questionnaire to investigate the depression and anxiety
DIAGNOSTIC_TEST	Fibromyalgia rapid screening tool	Standardized questionnaire to determine the presence of fibromyalgia
OTHER	Familial Mediterranean Fever Quality of life scale	Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients
OTHER	Jenkins Sleep Evaluation Scale	Standardized questionnaire to investigate the sleep quality and disturbance
OTHER	The Fatigue Severity Scale	Standardized questionnaire to investigate the fatigue severity

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2022-10-27
• Last updated: 2022-10-27

Locations

1 site across 1 country: Turkey (Türkiye)