Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever

Marmara University

Status: Enrolling

Conditions: Familial Mediterranean Fever; Autonomic Dysfunction

Treatments: Diagnostic Test: 30:15 ratio; Diagnostic Test: sympathetic skin response; Other: Familial Mediterranean Fever Quality of life scale; Other: Jenkins Sleep Evaluation Scale; Diagnostic Test: r-r interval variability with deep breathing; Other: Hospital anxiety and depression scale; Diagnostic Test: blood pressure response to sustained handgrip test; Diagnostic Test: blood pressure response to standing; Diagnostic Test: Composite Autonomic Symptom Score-31; Diagnostic Test: Fibromyalgia rapid screening tool; Diagnostic Test: r-r interval variability with normal breathing; Other: The Fatigue Severity Scale; Diagnostic Test: Valsalva ratio

Study type: Observational

Funder types: Other

Identifiers

NCT05596643

09.2021.1427

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Familial Mediterranean Fever group;

1. Being between the ages of 18-65
2. Having a definite diagnosis of Familial Mediterranean Fever according to Livneh criteria

Healthy control group;

1. Being between the ages of 18-65
2. Absence of any disease diagnosis

Exclusion criteria

1. Liver or kidney failure
2. Pregnancy
3. Diabetes mellitus
4. Thyroid diseases
5. Those who use neuroprotective or antihypertensive drugs
6. Vitamin B12 deficiency
7. Anemia
8. Paraneoplastic neuropathy
9. Alcoholism
10. Cardiac failure
11. Cardiac arrhythmia
12. Acute thrombosis
13. Having a diagnosis of another systemic rheumatic disease
14. Persons who did not give consent to participate in the study

Trial design

60 participants in 2 patient groups

Patients diagnosed with Familial Mediterranean Fever

Treatment:

Other: The Fatigue Severity Scale

Diagnostic Test: Fibromyalgia rapid screening tool

Diagnostic Test: Composite Autonomic Symptom Score-31

Diagnostic Test: 30:15 ratio

Other: Jenkins Sleep Evaluation Scale

Other: Hospital anxiety and depression scale

Diagnostic Test: blood pressure response to sustained handgrip test

Other: Familial Mediterranean Fever Quality of life scale

Diagnostic Test: blood pressure response to standing

Diagnostic Test: sympathetic skin response

Diagnostic Test: Valsalva ratio

Diagnostic Test: r-r interval variability with normal breathing

Diagnostic Test: r-r interval variability with deep breathing

Healthy Controls

Treatment:

Other: The Fatigue Severity Scale

Diagnostic Test: Fibromyalgia rapid screening tool

Diagnostic Test: Composite Autonomic Symptom Score-31

Diagnostic Test: 30:15 ratio

Other: Jenkins Sleep Evaluation Scale

Other: Hospital anxiety and depression scale

Diagnostic Test: blood pressure response to sustained handgrip test

Diagnostic Test: blood pressure response to standing

Diagnostic Test: sympathetic skin response

Diagnostic Test: Valsalva ratio

Diagnostic Test: r-r interval variability with normal breathing

Diagnostic Test: r-r interval variability with deep breathing