Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever

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

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

Sponsors & Collaborators

• Marmara University

  lead OTHER

Principal Investigators

• Mehmet Tuncay Duruöz, Prof · Marmara University

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-15

Primary Completion

2022-10-31

Completion

2022-10-31

Countries

• Turkey (Türkiye)

Study Locations